Formulaite R&D Report

Current Formulation: NONE (create formula from scratch)

Delivery Type: Oral capsule

Units per day: 3

Target Users: Adults with diabetes and obesity, focused on muscle preservation

Requirements: All-Ayurvedic ingredients

Regulatory Frameworks: India: India (AYUSH)

Manufacturing Specifications: None, Capsule size: 0

Focus: Add Only (From Scratch)

Desired Benefits: GLP-1-like activity, GIP-like activity, glucagon-like activity, metabolic support, blood sugar regulation, weight management, muscle preservation / no muscle wasting

Target Market Region: India

4 ingredient(s) appear ready to source. 1 ingredient(s) should be quoted before costing. Directional raw-material

COGS includes: Fenugreek seed extract (standardized to 50% saponins), Black pepper extract (Piper nigrum, standardized to 95% piperine), Gymnema sylvestre leaf extract (standardized to 25% gymnemic acids), Bitter Melon fruit extract (Momordica charantia, standardized to 10% charantin).

Cost Signal: Est. ₹0.484 per capsule; ₹1.45 per daily dose (3 capsules); ₹43.59 per 30-day supply (90 capsules)

Displayed in INR using 1 USD = 95.12 INR (2026-06-12).

Sourcing signals are for R&D screening. Confirm supplier quote, MOQ, lead time, COA, certifications, freight, duties, and landed cost before commercialization.

SYNERGY: gymnema + bitter melon + fenugreek

Polyherbal combination of gymnema, bitter melon, and fenugreek demonstrates synergistic hypoglycemic and antihyperglycemic effects. When combined, these three herbs show enhanced glucose regulation superior to individual herbs alone, with complementary mechanisms: gymnema stimulates insulin secretion from pancreatic beta-cells, bitter melon improves glucose uptake via GLUT4 upregulation, and fenugreek's 4-hydroxy isoleucine enhances insulin secretion. This combination is more effective than individual herbs at reducing blood glucose levels.

Ingredient Type: New

• Source 1: Journal - https://pubmed.ncbi.nlm.nih.gov/39991425/
• Source 2: Journal - https://pubmed.ncbi.nlm.nih.gov/38500279/
• Source 3: Journal - https://pubmed.ncbi.nlm.nih.gov/19904502/

INCOMPATIBILITY: piperine + warfarin

Piperine inhibits CYP2C and CYP3A enzymes responsible for warfarin metabolism, reducing 7hydroxywarfarin metabolite formation by 6-fold and potentially decreasing warfarin's anticoagulation efficacy. This represents a significant clinical safety concern for patients on anticoagulant therapy.

Ingredient Type: New

Type: Medicine Interaction

• Source 1: Journal - https://doi.org/10.2147/JEP.S257919
• Source 2: Journal - https://doi.org/10.1016/j.heliyon.2024.e31266

Analysis of 5 top competing products in the market

Competitor Products

1. Himalaya Diabecon DS Tablet: https://himalayawellness.in/products/diabecon-ds

2. Zandu Methi Capsules (Fenugreek): https://zanducare.com/products/methi-extract

3. Herb Biotic Diofin Capsules: https://www.amazon.in/DiofinDiofin-Sylvestre-Fenugreek-Ayurvedic-Management/dp/B0GW1837KS

4. Sheopal's Herbal Diabdex Capsule: https://www.sheopals.com/products/herbal-diabdex-care-capsule

5. Unicare Diabetes Alert Tablet: https://unicareremedies.com/product/diabetes-alert-blood-sugar-type-2-diabetes-control/

Competitor Reviews

Himalaya Diabecon DS Tablet by Himalaya Wellness

Customer feedback for Himalaya Diabecon DS Tablet

PRAISE: https://himalayawellness.in/products/diabecon-ds

"Reliability. I have been taking it for more than 20 years. My sugar levels are always within acceptable limits."

PRAISE: https://himalayawellness.in/products/diabecon-ds

"Fantastic! controls sugar"

COMPLAINT: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"Very worst product, skin is allergic by using even 1 tablet"

COMPLAINT: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"no results it is not effective please dont waste money on this"

PRAISE: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"Mild effect on sugar control Take 10 minutes minutes before meal. Meal should not have high GI food"

PRAISE: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"Daibicon is working well I had stopped metformin."

PRAISE: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"Very effective I trust himalaya medicine in 2016 for kidney stone. In left was 5 and right was 9 stone. Within 15 days all removed through urine And now this diabecon ds works from same day"

PRAISE: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"Actually my wife is consuming the medicine although she is not diabetic but the medicine is very effective her sugar level normal whenever I have measured"

PRAISE: https://www.1mg.com/otc/himalaya-diabecon-ds-tablet-manages-blood-sugar-level-otc268145

"Very effective Using for last one year My blood sugar has come down"

PRAISE: https://www.flipkart.com/himalaya-diabecon-ds-tablets/product-reviews/itm86b5ea70814b7?pid=AYDG9SFZSSJZXEAG

"Using it regularly with my diabetes medicine and bp tablets. It's effective"

PRAISE: https://www.flipkart.com/himalaya-diabecon-ds-tablets/product-reviews/itm86b5ea70814b7?pid=AYDG9SFZSSJZXEAG

"Very effective!"

COMPLAINT: https://www.flipkart.com/himalaya-diabecon-ds-tablets/product-reviews/itm86b5ea70814b7? pid=AYDG9SFZSSJZXEAG

"Not satisfied with your product. all the tablet inside has become powder"

Zandu Methi Capsules (Fenugreek) by Zandu Care

Customer feedback for Zandu Methi Capsules (Fenugreek)

PRAISE: https://www.1mg.com/otc/zandu-methi-fenugreek-capsule-for-healthy-sugar-levels-otc542283

"Very Good product. Effective"

PRAISE: https://www.1mg.com/otc/zandu-methi-fenugreek-capsule-for-healthy-sugar-levels-otc542283

"Good product"

PRAISE: https://www.1mg.com/otc/zandu-methi-fenugreek-capsule-for-healthy-sugar-levels-otc542283

"Good Product"

PRAISE: https://zanducare.com/products/methi-extract

"Good for prediabetic to overcome medicinal side effects"

PRAISE: https://zanducare.com/products/methi-extract

"Very effective in diabetes"

PRAISE: https://zanducare.com/products/methi-extract

"It's really good for sugar patient"

COMPLAINT: https://zanducare.com/products/methi-extract

"Taking too much time in this era of quick commerce"

Herb Biotic Diofin Capsules by Herb Biotic

No customer reviews collected for this product

Sheopal's Herbal Diabdex Capsule by Sheopal's

Customer feedback for Sheopal's Herbal Diabdex Capsule

PRAISE: https://www.amazon.in/Sheopals-Herbal-Diabetes-Capsule-Insulin/dp/B0BH46ZGH1

"I have been using Sheopal's Ayurvedic Herbal Diabdex Diabetes Care Capsule for the past month, and the results have been phenomenal. Since incorporating Diabdex into my daily routine, I have noticed a significant improvement in my blood sugar levels and overall energy."

PRAISE: https://www.amazon.in/Sheopals-Herbal-Diabetes-Capsule-Insulin/dp/B0BH46ZGH1

"This is the most effective product that I have ever used. I have tried almost everything but never saw such amazing results. I am using it from last 15 days and my sugar levels are already in control."

PRAISE: https://www.amazon.in/Sheopals-Herbal-Diabetes-Capsule-Insulin/dp/B0BH46ZGH1

"the product is very good, i am using this from a while there is no side effects and the results are awesome"

COMPLAINT: https://www.amazon.in/Sheopals-Herbal-Diabetes-Capsule-Insulin/dp/B0BH46ZGH1

"Product was ok but not as much as effective"

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"It's helped me manage my sugar levels without any side effects."

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"Great product for managing blood sugar levels effectively."

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"I'm very happy with the results. This product really works!"

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"These capsules are a game-changer for natural sugar management."

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"This product has helped me stabilize my sugar levels naturally."

COMPLAINT: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"Your service is very bad. You sent us 12 Caps instead of 30 deliberately. This same thing happened to some other friends also."

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"Highly effective and worth every penny. Great product!"

PRAISE: https://www.sheopals.com/products/herbal-diabdex-care-capsule

"I've seen visible improvements in my sugar levels within a month."

Unicare Diabetes Alert Tablet by Unicare Remedies

Customer feedback for Unicare Diabetes Alert Tablet

PRAISE: https://unicareremedies.com/product/diabetes-alert-blood-sugar-type-2-diabetes-control/ "Absolutely love it! Will be buying more in the future."

PRAISE: https://unicareremedies.com/product/diabetes-alert-blood-sugar-type-2-diabetes-control/ "Outstanding value for money."

PRAISE: https://unicareremedies.com/product/diabetes-alert-blood-sugar-type-2-diabetes-control/ "Amazing performance."

PRAISE: https://unicareremedies.com/product/diabetes-alert-blood-sugar-type-2-diabetes-control/ "Absolutely fantastic product. Does everything as described."

Total reviews collected: 35

Analysis

Original Formula vs Competitors

Market Gaps:

• Muscle preservation and protein metabolism support - no competitor explicitly features ingredients targeting lean muscle maintenance during weight loss (consider evaluating: Shatavari for anabolic support, Vidari Kanda for tissue nourishment, or Bala for strength)
• Comprehensive metabolic support - competitors focus heavily on glucose management but lack multi-pathway metabolic optimization (consider evaluating: Guggul for lipid metabolism, Triphala for digestive efficiency affecting nutrient absorption)
• Adaptogenic stress management during weight loss - limited inclusion of stress-response herbs that support hormonal balance during caloric restriction (consider evaluating: Ashwagandha prevalence is low across competitors despite its relevance)
• Digestive enzyme and agni (metabolic fire) enhancement - most competitors lack specific digestive support which impacts nutrient bioavailability and weight management (consider evaluating: Pippali, Shunthi, or Chitrak for agni enhancement)
• Satiety and appetite regulation - no competitor explicitly addresses hunger management or GI motility for weight loss support (consider evaluating: Isabgol or Psyllium husk compatibility with Ayurvedic framework)
• Liver and detoxification support - minimal focus on hepatic function despite its critical role in glucose metabolism and weight management (consider evaluating: Bhumi Amla, Kutki, or enhanced Neem formulation)

Competitive Advantages (before making new formula):

• Opportunity to differentiate through dual-action positioning: diabetes + obesity + muscle preservation creates a unique therapeutic niche that no competitor explicitly addresses
• Potential to create a more targeted daily regimen (3 units/day) versus competitors' varying dosage patterns allows for optimized timing (e.g., pre-meal glucose support, post-meal metabolic boost, evening recovery)
• Chance to emphasize synergistic ingredient combinations rather than broad-spectrum approaches - competitors tend toward 'kitchen sink' formulations with 8-12 ingredients; a focused, science-backed combination could offer better bioavailability
• Opportunity to highlight muscle-sparing mechanisms during weight loss - a significant gap that resonates with modern fitness-conscious diabetic populations

Competitive Disadvantages (before making new formula):

• Breadth of glucose-management ingredients - Herb Biotic Diofin (9 ingredients) and Unicare Diabetes Alert (12 ingredients) offer more comprehensive blood sugar support through multiple pathways; your formulation should consider whether it matches this depth in glucose regulation
• Established ingredient combinations - competitors like Sheopal's Diabdex combine proven synergies

(Ashwagandha + Gudmar + Karela + Methi); these combinations have market validation and consumer familiarity

• Adaptogenic inclusion - Sheopal's includes Ashwagandha (stress/cortisol management during weight loss); if your formulation lacks this, you're missing hormonal support critical for obesity management
• Liver and detoxification focus - Unicare's inclusion of Kalmegh and Herb Biotic's Chirayata provide hepatic support; if absent from your formulation, you lack this metabolic pathway
• Ingredient standardization and extract forms - competitor listings don't specify standardization levels, but established brands likely use standardized extracts; ensure your formulation specifies bioavailable forms to compete on efficacy claims
• Market presence and consumer trust - Himalaya, Zandu, and Herb Biotic have established distribution and brand recognition; a new formulation must overcome this through clear differentiation

Key Differences:

• Competitor strategy: Broad-spectrum glucose management (8-12 ingredients targeting multiple pathways) vs. potential opportunity for focused, synergistic combinations (5-7 ingredients with muscle preservation angle)
• Ingredient philosophy: Most competitors emphasize traditional glucose-lowering herbs (Gymnema, Gudmar, Karela, Methi appear in 4-5 products); your formulation should consider whether to follow this consensus or differentiate through underutilized ingredients
• Adaptogenic inclusion: Only Sheopal's prominently features Ashwagandha; this is a gap most competitors haven't filled despite its relevance to stress-induced weight gain and cortisol management
• Dosage strategy: Competitors don't specify daily unit consumption; your 3-unit/day structure allows for timeoptimized dosing (e.g., pre-meal, post-meal, evening) - this is a formulation advantage if leveraged in marketing
• Muscle preservation angle: Zero competitors explicitly address lean mass preservation - this is a white space opportunity that aligns with modern fitness trends and diabetic health outcomes

Recommendations:

• You should consider evaluating whether your formulation includes at least 2-3 glucose-management ingredients from the 'consensus cluster' (Gymnema, Gudmar, Karela, Methi) to ensure competitive efficacy perception, while differentiating through muscle-preservation and metabolic support ingredients
• You should think about incorporating an adaptogenic ingredient (Ashwagandha or Shatavari) to address stressinduced metabolic dysfunction and cortisol-related weight gain - this is underrepresented in competitors despite clinical relevance
• You should consider adding digestive/agni-support ingredients (Pippali, Shunthi, or Chitrak) to enhance bioavailability of glucose-regulating herbs and support metabolic efficiency - this addresses a market gap in nutrient absorption optimization
• You should think about evaluating liver-support ingredients (Bhumi Amla, Kutki, or enhanced Neem) to differentiate on hepatic metabolic pathways - competitors largely ignore this despite its importance in glucose and lipid metabolism
• You should consider positioning your 3-unit/day dosage as a strategic advantage by creating a time-optimized regimen (e.g., Unit 1: pre-meal glucose support; Unit 2: post-meal metabolic boost; Unit 3: evening muscle recovery/ hormonal support) - this differentiates from competitors' generic dosing
• You should think about whether to include a satiety or GI-motility ingredient to address appetite regulation during weight loss - this is completely absent from competitors and fills a behavioral/lifestyle gap
• You should consider conducting comparative bioavailability studies on your formulation versus Herb Biotic Diofin and Sheopal's Diabdex (the most comprehensive competitors) to substantiate efficacy claims and justify premium positioning
• You should think about emphasizing muscle preservation in marketing and clinical messaging - this is a unique selling proposition that no competitor addresses and resonates with modern fitness-conscious diabetic demographics
• You should consider whether standardized extracts or specific bioactive concentrations (e.g., gymnemic acids %, gudmar glycosides %) should be specified to differentiate on quality and efficacy versus competitors who may not disclose these details

Competitive Impact of Improvements

Summary:

The formulation now establishes a science-backed, multi-pathway glucose and metabolic control platform that directly addresses the competitive gap in synergistic ingredient combinations. By combining five standardized extracts (Gymnema, Bitter Melon, Fenugreek, Triphala, and Black Pepper) with documented complementary mechanisms—DPP-4 inhibition, peripheral insulin sensitivity, pancreatic beta-cell stimulation, alpha-glucosidase inhibition, and bioavailability enhancement—the product achieves mechanistic depth comparable to or exceeding competitors like Herb Biotic Diofin and Sheopal's Diabdex while maintaining a focused, efficacy-optimized formulation.

The 3-unit/day dosage structure (438mg total active ingredients per day across three capsules) enables timeoptimized positioning (pre-meal glucose support, post-meal metabolic boost, evening recovery) that competitors do not explicitly leverage. Fenugreek's dual action on glucose regulation and muscle preservation/strength gains directly fills the white-space opportunity in lean mass support during weight loss, differentiating from all competitors.

Standardized extract specifications (gymnemic acids %, charantin %, saponins %, piperine %) and documented synergistic mechanisms provide substantiated efficacy claims that overcome the market presence disadvantage through clinical credibility and clear differentiation on quality and bioavailability versus established brands.

1. Fenugreek seed extract (standardized to 50% saponins)

NEW INGREDIENT

Amount: 150mg per capsule

Sourcing Readiness:

Fenugreek seed extract standardized to 50% saponins is readily available from Indian manufacturers at ₹600–₹800/kg

(approximately $7–$10/kg USD equivalent) for bulk orders of 25 kg or more. Hill Natural Extract LLP (Greater Noida, Uttar Pradesh) is a verified GMP-compliant manufacturer and exporter offering the exact requested grade at ₹600/kg for 25 kg packs, with water-extraction method, 36-month shelf life, and export credentials to the US, UK, and other markets. Rudra

Bioventures (Bengaluru) offers a mid-range alternative at ₹800/kg for 10–25 kg packs, though their listing presents 50% saponins as one of two marker options (80% galactomannans also available at the same price). A premium marketplace listing from Greenwell Overseas (Ahmedabad) quotes ₹2,800/kg but reflects smaller pack sizes (5 kg minimum) and is not representative of production-scale COGS. All suppliers confirm nutraceutical-grade extract with 50% saponin assay and water-extraction method. Lead times are typically 7 days from India; MOQ is 25 kg for best pricing and verified manufacturer quotes

Next Step: Confirm supplier quote, COA, freight, duties, lead time, and certifications before purchase.

Order quantity: 25 kg

Supplier leads (directional — confirm exact grade, MOQ, and COA):

Directional listings (not in cost range):

Source Links:

Greenwell Overseas

Rudra Bioventures Private Limited

Hill Natural Extract LLP

Amount Range: 100–167mg per capsule

Benefit: Significant reduction in fasting blood glucose, 2-hour post-load plasma glucose, and HbA1c in adults with type 2 diabetes and prediabetes via oral supplementation, with complementary lipidprofile improvement (total cholesterol, triglycerides, HDL-C). Additionally, fenugreek saponin/ glycoside extract produces significant improvements in body composition—specifically reduced body fat percentage—and increases in upper- and lower-body strength (bench press and leg press 1-RM) in human RCTs, supporting muscle preservation and anti-obesity goals. Fenugreek provides a distinct, additive mechanism to Gymnema sylvestre leaf extract (insulin secretion via pancreatic beta-cells) and Bitter Melon fruit extract (GLUT4-mediated peripheral glucose uptake), completing the documented three-herb synergistic triad for multi-target blood sugar regulation.

Regulatory Compliance:

Scientific Basis: GLYCEMIC & METABOLIC EVIDENCE: Kim et al. (2023, DOI 10.3390/ijms241813999)

• a systematic review and meta-analysis of 10 RCTs (706 participants) — found that oral fenugreek significantly reduced fasting blood glucose (FBG), 2-hour plasma glucose (OGTT), and HbA1c versus control, while also significantly improving total cholesterol, triglycerides, and HDL-C in adults with T2DM and prediabetes. No hepatic or renal toxicity was observed. MUSCLE, STRENGTH & BODY

COMPOSITION EVIDENCE: Poole et al. (2010, PMID 20979623) conducted a double-blind, placebocontrolled RCT in 49 resistance-trained men randomised to 500mg/day fenugreek extract or placebo for 8 weeks. Significant group × time interaction effects were observed for body fat (fenugreek: −2.3 ± 1.4 %BF vs. placebo: −0.39 ± 1.6 %BF, p<0.001), lower-body strength — leg press 1-RM (fenugreek: +84.6 ± 36.2 kg vs. placebo: +48.0 ± 29.5 kg, p<0.001) — and upper-body strength — bench press 1-

RM (fenugreek: +9.1 ± 6.9 kg vs. placebo: +4.3 ± 5.6 kg, p=0.01). No significant changes in clinical safety data (lipid panel, liver/kidney function, CBC) were detected. This directly demonstrates that a saponin-enriched fenugreek extract simultaneously supports body fat reduction and muscle strength preservation — core targets for this formulation's muscle preservation and weight management goals. Wankhede et al. (2016, PMID 30356905) corroborates in a separate RCT (60 males, fenugreek glycoside 600mg/day, 8 weeks resistance training): significant anabolic and androgenic activity, significant improvements in body fat without reduction in muscle strength or repetitions to failure;

safe and well-tolerated. Rao et al. (2023, PMID 37637219) further corroborates in females: 600mg fenugreek over 8 weeks showed significant group × treatment effect for leg press at week 8 and dose-related changes in body composition and ergogenic parameters — extending muscle/body composition evidence beyond male-only cohorts. STANDARDIZATION ALIGNMENT: The Poole 2010 study used 500mg/day of a proprietary fenugreek extract (saponin-enriched, standardized fraction).

Assuming typical commercial saponin content of ~20–30% in the study extract, the study's bioactive dose was approximately 100–150mg saponins/day. Proposed: 150mg extract (50% saponins) × 3 capsules/day = 450mg extract/day delivering 225mg saponins/day. This represents a higher saponin delivery than the Poole 2010 estimate; however, the 450mg/day total extract dose remains below or comparable to the 500–600mg/day used across muscle RCTs, and delivers saponin content within the range studied in fenugreek saponin-enriched preparations (Wankhede 2016, Fenfuro® trial PMID 37459747). The Kim 2023 meta-analysis included RCTs with crude seed powder doses of 2–25g/day;

the standardized extract approach provides far more concentrated and consistent bioactive delivery.

No serious adverse events were reported in any of the cited human trials. SAFETY NOTE: Given the additive blood-glucose-lowering effects of the five herbal agents in this formulation, patients on antidiabetic medications should consult a healthcare provider and monitor blood glucose closely to avoid hypoglycemia.

Primary Reference: 10.1186/1550-2783-7-34

Additional Supporting Studies:

• https://doi.org/10.1080/15376516.2025.2567419 Fenfuro fenugreek seed extract studied for hyperglycemia, AGE prevention, insulin signaling—directly corroborates glucose-lowering benefit.
• https://pubmed.ncbi.nlm.nih.gov/41038677/ Fenugreek seed flakes reduce 24-hour glycemic variability in type 2 diabetes adults, corroborating glucose-lowering benefit.
• https://doi.org/10.4103/ijp.ijp_736_23 4-HIL from fenugreek seed extract is insulin secretagogue/glucoselowering agent; pharmacokinetics for diabetes management corroborates mechanism.
• https://doi.org/10.1097/MS9.0000000000001750 Systematic review/meta-analysis of fenugreek RCTs confirming glucose-lowering and cardiovascular/lipid benefits in diabetic patients.
• https://doi.org/10.7759/cureus.74571 Fenugreek seed extract with furostanolic saponins improves lipid profile and insulin resistance in PCOS women—corroborates saponin mechanism and lipid benefits.
• https://doi.org/10.1080/15376516.2024.2358520 Fenfuro fenugreek seed extract with furostanolic saponins inhibits methylglyoxal adducts, supporting anti-hyperglycemic mechanism corroboration.
• https://doi.org/10.1080/27697061.2023.2233008 Fenfuro furostanolic saponin extract RCT in 204 T2DM patients showing efficacy—directly corroborates glucose-lowering benefit.
• https://doi.org/10.3390/ijms241813999 Systematic review and meta-analysis of fenugreek RCTs confirming glycemic control and lipid profile benefits in T2DM and prediabetes.
• https://doi.org/10.1016/j.dsx.2023.102826 Network meta-analysis comparing herbs including fenugreek for T2DM glycemic management—corroborates glucose-lowering benefit.

Corroborating Evidence: Backed by 165 additional studies

2. Black pepper extract (Piper nigrum, standardized to 95% piperine)

NEW INGREDIENT

Amount: 5mg per capsule (providing ~4.75mg piperine)

Sourcing Readiness:

Black pepper extract standardized to 95% piperine is readily available from multiple Indian manufacturers at production scale (25 kg MOQ). Bulk pricing clusters around ₹15,000–₹18,000/kg (approximately USD $18–26/kg), with solventextracted, pharma-grade material confirmed by suppliers including Bio Extract, Aurika Naturals, and Aora India. All major listings include HPLC assay, FSSAI certification, and 2–3 year shelf life. Sourcing is straightforward via IndiaMART or direct contact; expect quote-based pricing and 7–14 day lead times for 25 kg orders. Avoid outlier listings below ₹10,000/ kg, which lack credible extract manufacturing language or show implausible price–grade inconsistency

Next Step: Confirm supplier quote, COA, freight, duties, lead time, and certifications before purchase.

Order quantity: 25 kg

Supplier leads (directional — confirm exact grade, MOQ, and COA):

Directional listings (not in cost range):

Source Links:

Bio Extract

Aurika Naturals LLP

Aora India Private Limited

Amount Range: 5–10mg per capsule

Benefit: Bioavailability enhancement for co-formulated herbal extracts (Gymnema sylvestre leaf extract, Bitter Melon fruit extract, Fenugreek seed extract, and Triphala extract) by inhibiting hepatic and intestinal first-pass metabolism via CYP3A4 and P-glycoprotein inhibition. Co-administration with curcuminoids and piperine has also demonstrated significant reductions in fasting blood glucose, triglycerides, and improvements in energy/fatigue scores in adults with type 2 diabetes mellitus.

Ayurvedic Basis:

Piper nigrum (Black Pepper / Marica) appears extensively throughout classical Ayurvedic texts under the traditional names Marica and as part of the Trikatu combination.

Classical Properties:

According to Charaka-Samhita, Piper nigrum is classified among the 'Trikatu' (three acrids) along with dry ginger and long pepper. The texts describe related properties: pungent, becoming sweet upon assimilation, oily and hot, and employed as media or vehicles for other medicines. Piper nigrum appears among 'Dipana' drugs (digestive fire-kindling medicines) in Charaka-Samhita discussions of digestive disorders.

Classical Formulations:

1. KUMARYASAVA (Sarngadharasamhita, Madhyamakhanda, Adhyaya 10, 18-24%): Marica (Fr.) 24 g.

Classical indications: agnimandya (weak digestive fire / poor digestion); udavartta (upward movement of vata); mutrakrccha (difficult urination); prameha (urinary disorders including diabetes-like conditions); asmari

(stone formation / calculi); raktapitta (bleeding disorders); apasmara (epilepsy / loss of consciousness);

sukradosa (disorders of reproductive fluid / semen quality issues); krmi (parasitic infections); smrtiksaya

(loss of memory); daurbalya (weakness); udara (abdominal disorders / dropsy); karsya (emaciation / wasting).

2. HINGVASTAKA CURNA (Bhaisajyaratnavali, Agnimandyadirogadhikara, 37): Marica (Fr.) 3 g. Classical

indications: agnimandya (weak digestive fire); sula (deep-seated pains); gulma (abdominal tumors / masses); vataroga (disorders of vata / wind diseases).

3. TRIKATU CURNA (Bhaisajyaratnavali, Paribhasaprakarana, 16): Pippali (1 part), Marica (1 part), Sunthi (1

part). Classical indications: arocaka (loss of appetite); agnimandya (weak digestive fire); ama dosa

(indigestion / toxic byproducts); gala roga (throat disease); pinasa (nasal inflammation / rhinitis); kustha

(skin diseases); svasa (asthma / breathing difficulties); kasa (cough); tvakroga (skin disease); gulma

(abdominal masses); meha (urinary disorders); sthaulya (obesity); slipada (elephantiasis / lymphatic obstruction).

4. TALISADYA CURNA (Sarngadharasamhita, Madhyamakhanda, Adhyaya 6, 130-131%): Marica (Fr.) 24 g.

Classical indications: chardi (vomiting); adhmana (abdominal distension); kasa (cough); svasa (asthma); jvara (fever); aruci (loss of appetite); ajima (indigestion); atisara (diarrhea); sosa (wasting); pliha (splenic disorders); grahani (chronic digestive dysfunction); pandu (anemia).

5. BRHAT SAINDHAVADYA TAILA (Bhaisajyaratnavali, Amavatadhikara, 157-159): Marica (Fr.) 24 g.

Classical indications: anaha (abdominal distension / constipation); antravrddhi (intestinal enlargement); mitra krcchra (difficult urination); aSmari (stone formation); hrtsila (cardiac pain); parsvaSula (side pain); ardita (facial paralysis); amavata (rheumatoid arthritis); sandhigata vata (joint arthritis); mandagni (weak digestive fire); vataroga (wind disorders); katisila (lumbar pain); januSula (knee pain); UruSila (thigh pain); prsthasila (back pain); bahyayama (external pain).

6. CANDRODAYA VARTTI (Bhaisajyaratnavali, Netrarogadhikara, 105-105%): Marica (Fr.) 1 part. Classical

indications: timira (opacity / cataracts); patala arbuda (pterygium); netra adhimamsa (conjunctival hypertrophy); ratryandha (night blindness); sikafa vartma (eyelid disease); kandu (itching).

7. DANTA VARTTI (Astangahrdaya, Uttarasthana, Adhyaya 11, 33-33%): Marica (Fr.) 2½ parts, mixed with

honey and applied to inner eyelids. Classical indications: savrana sukra (suppurative discharge); avrana sukra (non-suppurative discharge).

8. MUKTADI MAHANJANA (Bhaisajyaratnavali, Netrarogadhikara, 242-243): Marica included in formula,

mixed with honey and applied to internal eye-lids.

In Charaka-Samhita treatments for phlegm-born diarrhea (atisara), Piper nigrum appears in combination:

"Black Ajaji (otherwise called Krishnajiraka, i.e., the seeds of Nigella sativa), Pstha (Cissampelos hernandifolia), Nagara (dry ginger), and Maricha (black pepper), the measure of each being equal, with Dhataki (Woodfordia floribunda) of twice the measure: Reduce these to pulv and dissolve the pulv in the expressed juice of Matulunga (Citrus medico)."

Piper nigrum also appears in classical Narayana-churna preparation as a component ingredient. The herb

appears in synergistic combination with Pippali (long pepper), Sunthi (dry ginger), Triphala (the three myrobalans), and various digestive and circulatory tonics.

Classical Indications May Relate to Desired Benefits: Multiple classical indications suggest potential relevance: agnimandya (weak digestive fire) and dipana properties may relate to metabolic support; prameha and meha (urinary disorders including diabetes-like conditions) may relate to blood sugar regulation; sthaulya

(obesity) and karsya (emaciation/wasting) may relate to weight management and muscle preservation; mandagni (weak digestive fire) appears across digestive formulations relevant to metabolic function.

Regulatory Compliance:

Scientific Basis: Hosseini et al. (2024, PMID 39165011) conducted a double-blind randomized controlled trial in 72 adults with type 2 diabetes mellitus and hypertriglyceridemia. Participants received an oral tablet containing 500mg curcuminoids plus 5mg piperine, or matched placebo, for 12 weeks. The piperine-containing group demonstrated significantly reduced fasting blood glucose

(p=0.004) and triglycerides (p=0.001) versus placebo, and energy/fatigue scores significantly improved (p=0.024). The study population directly matches the target users (adults with T2DM and metabolic dysfunction). Study standardization: piperine was administered as 5mg pure piperine per dose — this is the actual bioactive dose used in the study. Proposed standardization: 95% piperine extract. Proposed dosage: 5mg extract per capsule delivering ~4.75mg piperine per capsule

(~14.25mg piperine/day across 3 capsules). The 5mg per capsule dose is the internationally recognized standard minimum effective dose for piperine as a bioavailability enhancer and directly matches the study's piperine dose on a per-unit basis, adding only 5mg of mass per capsule.

REGULATORY NOTE: The BfR (German Federal Institute for Risk Assessment, 2021) has recommended a maximum of 2mg/day for isolated piperine in food supplements, citing CYP3A4/Pgp-mediated drug interaction concerns. At 3 capsules/day, the proposed total daily piperine intake

(~14.25mg/day) exceeds this limit. This formulation is intended for the Indian market under AYUSH regulations, where black pepper (Maricha/Piper nigrum) is a classical Ayurvedic co-ingredient used at traditional doses, and the BfR limit is not a binding constraint. However, for target populations on antidiabetic medications, a healthcare provider consultation warning is essential. The piperine minimum effective dose rule mandates no reduction below 5mg/capsule, as this is the established minimum for P-glycoprotein and CYP3A4 inhibition-based bioavailability enhancement. Black pepper (Piper nigrum, known as 'Maricha' in Ayurveda) is a classical Ayurvedic ingredient, fully compliant with the all-Ayurvedic ingredient requirement.

Primary Reference: 10.1002/ptr.8304

Additional Supporting Studies:

• https://doi.org/10.1016/j.fitote.2026.107091 Piperine in novel compound mixture reduces hyperglycemia and dyslipidemia in diabetic rats, corroborating glucose/triglyceride reduction.
• https://doi.org/10.1007/s40200-025-01799-y Meta-analysis shows curcumin+piperine cosupplementation improves glycemic control in adults, corroborating piperine's role in glycemic management.
• https://doi.org/10.1038/s41598-025-05137-3 Piperine enhances intestinal absorption and pharmacokinetics, directly corroborating bioavailability potentiation mechanism described in main study.
• https://doi.org/10.1186/s40360-025-00836-z Piperine as bioenhancer improves bioavailability of antihyperlipidemic drug by inhibiting first-pass metabolism, corroborating bioavailability potentiation mechanism.
• https://doi.org/10.1007/s11095-025-03920-5 Directly describes piperine's bioenhancing via CYP3A4 inhibition and P-gp inhibition, corroborating first-pass metabolism inhibition mechanism in main study.
• https://doi.org/10.15605/jafes.039.01.18 Curcumin+piperine supplementation improves fasting plasma glucose and HOMA-IR in T2DM patients, corroborating glycemic benefit.
• https://doi.org/10.1002/fsn3.3965 Black pepper in breakfast affects postprandial glycemia in adults, corroborating glucose-lowering benefit of black pepper.
• https://doi.org/10.7759/cureus.54061 Piperine reduces blood glucose in T2DM rats via hepatic mechanisms, directly corroborating glucose reduction benefit.
• https://doi.org/10.1016/j.chroma.2024.465358 Piper nigrum identified as pancreatin inhibitor for antidiabetic activity, corroborating glucose-lowering mechanism of black pepper.

Corroborating Evidence: Backed by 61 additional studies

3. Gymnema sylvestre leaf extract (standardized to 25% gymnemic acids)

NEW INGREDIENT

Amount: 133mg per capsule (providing ~33mg gymnemic acids per capsule)

Sourcing Readiness:

Gymnema sylvestre extract standardized to 25% gymnemic acids is readily available from Indian manufacturers at bulk

MOQ (25–60 kg). Marketplace pricing ranges from approximately ₹950–₹2,300/kg (USD $11.40–$27.60/kg equivalent) on IndiaMART and TradeIndia. Credible suppliers include Bioprex Labs (₹2,300/kg, 25 kg MOQ, hydro-alcoholic extraction, GMP/ISO certified), All Season Herbs (₹950/kg, 60 kg MOQ, solvent extraction, ISO/FSSAI/KOSHER/HALAL certified), and S.A. Herbal Bioactives (₹1,150/kg, 25 kg MOQ, standardized extract, GMP/ISO/FSSAI certified). For your target 133 mg per capsule (25% grade), expect production-scale COGS in the USD $15–$25/kg range after quote negotiation. All suppliers offer 10–15 day lead times and 25 kg HDPE drum packaging. Pricing is directional; formal quotes required before commitment

Next Step: Confirm supplier quote, COA, freight, duties, lead time, and certifications before purchase.

Order quantity: 25 kg

Supplier leads (directional — confirm exact grade, MOQ, and COA):

Directional listings (not in cost range):

Source Links:

Bioprex Labs

All Season Herbs Private Limited

S. A. Herbal Bioactives LLP

Amount Range: 100–167mg per capsule (300–500mg extract daily)

Benefit: Blood glucose reduction via DPP-4 inhibition and elevation of circulating active GLP-1 in diabetic subjects, with complementary insulin secretion stimulation. DPP-4 is the enzyme responsible for rapid degradation of both major incretin hormones — glucagon-like peptide-1

(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) — so inhibiting DPP-4 activity simultaneously preserves intact, biologically active GLP-1 and GIP in circulation. The cited Kosaraju et al. (2014) study directly measured and confirmed significant elevation of plasma active GLP-1 following oral Gymnema sylvestre extract administration, consistent with DPP-4 inhibition. Because

DPP-4 is the primary catabolic enzyme for both GLP-1 and GIP, the same DPP-4 inhibitory mechanism documented for GLP-1 in the Kosaraju study is expected to confer parallel preservation of intact GIP; this dual incretin-preserving mechanism is well established in the DPP-4 inhibitor pharmacology literature. Together with direct beta-cell stimulation (Baskaran et al., 1990),

Gymnema sylvestre contributes multi-target incretin and insulin-secretory support for blood sugar regulation and metabolic control in adults with T2DM.

Regulatory Compliance:

Scientific Basis: DPP-4 INHIBITION AND GLP-1 ELEVATION (PRIMARY EVIDENCE): Kosaraju et al.

(2014, PMID 24074231, DOI 10.3109/13880209.2013.823550) demonstrated that oral Gymnema sylvestre extract inhibits dipeptidyl peptidase-4 (DPP-4) with an IC50 of 773.22 ± 9.21 µg/mL and a long enzyme inhibitory half-life of 153.8 minutes in vitro. In vivo, oral administration at 100–400 mg/kg in diabetic rats significantly increased plasma active GLP-1 levels versus negative control groups, with peak GLP-1 observed at 1.5 hours post-dose. The study concluded that Gymnema sylvestre's hypoglycemic action is attributed, at least in part, through an increase in plasma active

GLP-1 levels via DPP-4 inhibition. IMPORTANT TRANSPARENCY NOTE — GLP-1 vs. GIP: The Kosaraju 2014 study specifically measured plasma active GLP-1 only; it did not separately quantify

GIP levels. However, DPP-4 is the primary catabolic enzyme responsible for rapid degradation of BOTH major incretin hormones — GLP-1 and GIP. This is mechanistically established in the DPP-4 pharmacology literature: Aloke et al. (2025, PMID 41355613) explicitly state that 'DPP-4 inhibitors prolong the activity of incretin hormones (GLP-1 and GIP)' and 'preserving the levels of glucosedependent insulinotropic peptide and glucagon-like peptide-1'; Chayah et al. (2024, PMID 38618281) further confirm that 'the gut incretin hormones GLP-1 and GIP…are extensively metabolized by DPP-4' and that 'inhibitors of DPP-4 block the degradation of GLP-1 and GIP and may increase their natural circulating levels'. Therefore, the DPP-4 inhibitory activity of Gymnema sylvestre documented in Kosaraju 2014, while directly evidenced only through GLP-1 measurement, mechanistically implies concurrent preservation of intact GIP through the same enzyme inhibition pathway — consistent with the established pharmacology of DPP-4 inhibition across the class. The GIP-preserving inference is mechanistically grounded but not directly measured in the Gymnemaspecific study. CLINICAL HUMAN EFFICACY CORROBORATION: Baskaran et al. (1990, PMID

2259217) confirmed clinical efficacy in humans: 22 T2DM patients receiving GS4 (gymnema leaf

extract) at 400 mg/day orally for 18–20 months showed significant reductions in blood glucose, glycosylated haemoglobin, and glycosylated plasma proteins, with raised serum insulin levels — consistent with enhanced beta-cell function alongside the DPP-4/incretin mechanism.

STANDARDIZATION ALIGNMENT: GS4 is a gymnema leaf extract; standard commercial equivalents are typically standardized to ~25% gymnemic acids, giving ~100mg gymnemic acids at 400mg/day

• this is the assumed bioactive dose. Proposed dose: 133mg extract (25% gymnemic acids) per capsule × 3 capsules = 400mg extract/day and ~100mg gymnemic acids/day, directly matching the Baskaran human clinical dose in bioactive content. Study standardization for the Baskaran 1990 study: GS4 extract (assumed ~25% gymnemic acids) at 400mg/day ≈ ~100mg gymnemic acids/ day as bioactive dose. Proposed bioactive dose: 133mg × 25% = ~33mg gymnemic acids per capsule × 3 = ~100mg gymnemic acids/day. Bioactive doses are aligned.

Primary Reference: 10.3109/13880209.2013.823550

Additional Supporting Studies:

• https://doi.org/10.5493/wjem.v16.i1.116252 GS antidiabetic effects in T2DM rat model, evaluating glycemic control relevant to blood glucose reduction.
• https://doi.org/10.1002/cbdv.202500410 GS leaf extract antidiabetic effects in diabetic rats; directly tests

GSE on blood glucose.

• https://doi.org/10.7759/cureus.77806 GS hypoglycemic potential in sucrose tolerance test in rats; relevant to postprandial glucose reduction.
• https://doi.org/10.1111/jcmm.70349 Network pharmacology/molecular docking confirms gymnemic acids target DPP-4 and other antidiabetic proteins.
• https://doi.org/10.3390/jcm12247650 RCT with GS in T2DM patients showing improved glucose and lipid profiles; clinical corroboration.
• https://doi.org/10.1080/07391102.2023.2187231 Gymnemic acid shows binding affinity to diabetes target proteins including DPP-4; in silico corroboration.
• https://doi.org/10.1002/ptr.7265 Systematic review/meta-analysis confirming GS supplementation improves glycemic control in T2DM patients.
• https://pubmed.ncbi.nlm.nih.gov/34275855/ GS leaf extract reduces blood glucose and improves lipid profile in diabetic rats; corroborates antidiabetic benefit.
• https://doi.org/10.1002/ptr.6885 Reviews natural products regenerating beta-cells, relevant to GS insulin secretion stimulation mechanism.

Corroborating Evidence: Backed by 59 additional studies

4. Triphala extract (standardized to 45% tannins/polyphenols)

NEW INGREDIENT

Amount: 50mg per capsule (providing ~22.5mg tannins)

Sourcing Readiness:

Triphala extract standardized to 45% tannins is available from Indian suppliers, but transparent bulk pricing for the exact requested grade is not yet available. Star Hi Herbs (Bangalore) explicitly offers Triphala extract standardized to 20–45% tannins with MOQ 25 kg and holds relevant certifications (ISO 9001, FSSC 22000, WHO GMP, FSSAI), but requires a quote request. Lower-priced marketplace listings (₹249–₹450/kg on IndiaMART) appear to be ungraded or commodity-grade triphala powder, not standardized extracts, and are likely not suitable for your 45% tannin specification. We recommend requesting a formal quote from Star Hi Herbs specifying 45% tannin standardization and confirming bulk pricing at 25 kg

MOQ before proceeding

Next Step: Request supplier quote for exact grade, MOQ, lead time, COA, and landed cost.

Source Links:

Natcon Biolifesciences Private Limited

Savira Phytoextract

Star Hi Herbs Pvt Ltd

Amount Range: 33–67mg per capsule

Benefit: Reduction in body weight, BMI, waist circumference, and fasting blood glucose in obese and diabetic patients, with complementary improvement in lipid profiles (LDL-C, total cholesterol, triglycerides), via multi-target mechanisms including alpha-glucosidase inhibition, pancreatic lipase inhibition, and antioxidant activity. Triphala's tannin-rich polyphenol content (chebulinic acid, gallic acid, ellagic acid) provides a mechanistically distinct complement to the insulin secretion

(Gymnema sylvestre leaf extract), peripheral glucose uptake (Bitter Melon fruit extract), and fibermediated glucose blunting (Fenugreek seed extract) mechanisms already present in this formulation.

Ayurvedic Basis:

TRIPHALA: Classical Ayurvedic Properties and Formulations

Traditional Names and Composition:

Triphala (also called 'the three myrobalans') consists of three fruits: Haritaki (Terminalia chebula / Chebulic myrobalan), Bibhitaka (Terminalia bellirica / Belleric myrobalan), and Amalaki (Phyllanthus emblica / Emblic myrobalan).

Triphala Rasayana Formulation:

According to the Charaka Samhita, Cikitsasthana, Adhyaya 1, a classical Triphala Rasayana preparation is described: After the food (taken before) is digested, one should take one fruit of Haritaki before the (next) meal; take two fruits of Vibhitaka, and (just) after meals take four fruits of Amalaki. All these fruits should be taken with honey and ghee. This Rasayana of the three myrobalans should be taken for a whole year. By its use one would live for a full hundred years without being influenced by age, and without being afflicted by disease. From use of this Rasayana for a full year, one becomes free from decrepitude and disease and lives for a hundred years.

Alternative Triphala Rasayana Preparations:

According to the Charaka Samhita, Cikitsasthana, Adhyaya 1, the three myrobalans can also be used with: (1) the pulp of liquorice; (2) Tugakshiri (bamboo manna) reduced to pulp; (3) the pulp of Piper longum; (4) honey and ghee; or (5) sugar. These five different preparations of myrobalans have been well tried.

Advanced Triphala Rasayana Formulations:

The three myrobalans used with all varieties of iron reduced to powder, or with gold, or with Vacha (Acorus Calamus), or with honey and ghee, or with Vidanga (Embelia Ribes), or with (powdered) fruits of Piper longum, or with Saindhava salt, make a very potent Rasayana. If used for a full year, any of these Rasayanas would sharpen the understanding and the memory, and infuse strength. It would impart longevity. It is deserving of high praise; it counteracts the effects of age and alleviates diseases.

Triphala in Other Classical Formulations:

Avipattikara Churna (Bhaisajyaratnavali, Amlapittadhikara; 24-25):

This formulation contains Haritaki (P.) 1 part, Bibhitaka (P.) 1 part, and Amalaki (P.) 1 part. Important therapeutic uses include: agnimandya (weak digestive fire / poor digestion), malabandha (constipation / blocked bowels), amlapitta (acid reflux / acidic stomach disorders), arsa (hemorrhoids / piles), mutrabandha

(urinary obstruction / blocked urination), and prameha (urinary disorders including diabetes-like conditions).

Amalakyadi Churna (Sarngadharasamhita, Madhyamakhanda, Adhyaya 6; 7):

This formulation is described as 'sarvajvaravinasanah' (destructive of all fevers). It contains Pathya (haritaki)

(P.) 1 part as its component. Important therapeutic uses include: aruci (loss of taste/appetite), agnimandya

(weak digestive fire / poor digestion), jvara (fever), and ajirna (indigestion / poor digestion).

Intuppukana Churna (Sahasrayoga, Curnprakarana; 23):

This formulation contains Haritaki (P.) 6 parts. Important therapeutic use: agnimandya (weak digestive fire / poor digestion).

Manibhadra Yoga/Guda (Astangahrdaya, Cikitsasthana, Adhyaya 19; 31):

This formulation contains Abhaya (haritaki) (P.) 48 g. Dosage: 6g. It is used for a full twelve months.

Lasunadi Ghrta (Astangahrdaya, Cikitsasthana, Adhyaya 14; 22-25):

This formulation contains Haritaki (P.) 24 g, Bibhitaka (P.) 24 g, and Amalaki (P.) 24 g as component ingredients. Important therapeutic uses: gulma (abdominal tumors / masses), and vata roga (wind disorders / vata-type conditions).

Vajraka Ghrta (Astangahrdaya, Cikitsasthana, Adhyaya 19; 18):

This formulation contains Haritaki (P.), Bibhitaka (P.) 19.2 g, and Amalaki (P.) 19.2 g.

Dastimilarista (Charaka Samhita references):

Haritaki appears prominently in formulations indicated for various conditions including ksaya (wasting / tissue depletion), kasa (cough), and svasa (asthma / breathing difficulties).

Triphala in Classical Preparations for Specific Conditions:

For Leprosy/Kustha:

According to Charaka Samhita, Cikitsasthana, Adhyaya 7, verses 96-97: Triphala (the three myrobalans), Nimba, Patola, Manjishtha, Rohini (Picrorrhiza Kurroa), Vacha, and Rajani—the decoction of these, taken daily, cures leprosy born of phlegm and bile. Ghee boiled with these decoctions checks leprosy characterised by predominance of wind.

For Digestive Conditions:

The husk of Triphala (viz., the three myrobalans) is mentioned in classical preparations for leprosy and other skin conditions (Charaka Samhita, Cikitsasthana, Adhyaya 7).

Triphala as a Component in Multiple Formulations:

Triphala appears in numerous formulations throughout classical Ayurvedic texts including those for: rakta roga (blood disorders / conditions of vitiated blood), sotha (edema / swelling), kustha (skin diseases / leprosy-type conditions), arsa (hemorrhoids / piles), kamala (jaundice / liver disorders), and conditions related to digestive fire and elimination.

SOURCE TEXTS REFERENCED:

1. Ashtanga Hridayam

2. Bhaishajya Ratnavali

3. Charaka Samhita

4. Harita Samhita

5. Sahasrayoga

6. Sharngadhara Samhita

Regulatory Compliance:

Scientific Basis: Phimarn et al. (2021, PMID 33886393) conducted a systematic review of 12 RCTs

(749 patients) evaluating oral Triphala supplementation on lipid profiles, blood glucose, and anthropometric parameters. Five RCTs demonstrated that Triphala-treated groups showed statistically significant decreases in body weight, BMI, and waist circumference in obese patients.

Triphala significantly decreased fasting blood glucose levels in diabetic patients but not in nondiabetic individuals. Six studies showed significant reductions in LDL-cholesterol, total cholesterol, and triglycerides. No serious adverse events were reported across any included study. The study populations directly match the target users (adults with obesity and type 2 diabetes) and all included RCTs used oral administration. Study standardization: the RCTs included in this review primarily used crude Triphala churna (powder) at doses ranging from approximately 5–10g/day, which at a typical tannin content of ~4–6% equates to roughly 200–500mg tannins/day as the study bioactive dose range. Proposed ingredient: Triphala extract standardized to 45% tannins at 50mg/capsule delivering ~22.5mg tannins per capsule; across 3 capsules/day this provides

~67.5mg tannins/day. This represents approximately 15–34% of the estimated study bioactive tannin dose and is acknowledged as a sub-full-monotherapy dose necessitated by Size 0 capsule capacity constraints with co-formulated ingredients already occupying 388mg. However, the piperine co-formulated in this blend (Black pepper extract, 5mg/capsule) is well-established to enhance the bioavailability of polyphenols including tannin-class compounds, which may partially offset the reduced dose. Users seeking full Triphala monotherapy dosing (5–10g crude powder or ~500–1000mg standardized extract per day) should consider a dedicated Triphala supplement.

Primary Reference: 10.1177/2515690X211011038

Additional Supporting Studies:

• https://doi.org/10.1016/j.foodchem.2025.147619 Gallic acid alpha-glucosidase inhibition and glycemic control directly relevant to Triphala's tannin/polyphenol mechanisms.
• https://pubmed.ncbi.nlm.nih.gov/42069440/ Terminalia chebula (Triphala component) lipid-lowering effects in vivo directly corroborates lipid profile benefit.
• https://doi.org/10.1016/j.fitote.2025.106790 Gallotannins/ellagitannins inhibiting alpha-glucosidases directly supports Triphala tannin-mediated glycemic mechanism.
• https://doi.org/10.1016/j.ijbiomac.2025.144204 Gallotannins and ellagitannins inhibiting human brush border alpha-glucosidases directly corroborates Triphala tannin mechanism.
• https://pubmed.ncbi.nlm.nih.gov/39564797/ Phyllanthi Fructus contains ellagic acid/tannins; alphaglucosidase inhibition mechanism relevant to Triphala polyphenols.
• https://doi.org/10.1093/nutrit/nuaf159 Ellagic acid (Triphala component) effects on lipid profiles and anthropometric parameters directly corroborates benefit claims.
• https://doi.org/10.1016/j.phymed.2023.155229 Triphala directly studied for hypolipidemic effects and NAFLD prevention, corroborating lipid-lowering benefit.
• https://doi.org/10.1016/j.phymed.2023.155063 Plant gallotannins inhibiting alpha-glucosidases in vivo and in vitro directly supports Triphala tannin-mediated mechanism.
• https://pubmed.ncbi.nlm.nih.gov/35851119/ Hydrolyzable tannins (including galloyl/ellagitannin compounds) from pomegranate show antidiabetic activity; directly relevant to Triphala's tannin mechanisms.

Corroborating Evidence: Backed by 50 additional studies

5. Bitter Melon fruit extract (Momordica charantia, standardized to 10%

charantin)

NEW INGREDIENT

Amount: 100mg per capsule (providing ~10mg charantin per capsule)

Sourcing Readiness:

Bitter Melon extract standardized to 10% charantin is readily available from Indian manufacturers at ₹750–₹800/kg

(approximately $9–10/kg USD) for bulk orders of 5–25 kg. GR Herbals (TradeIndia) offers a verified listing with explicit 10% charantin standardization, solvent extraction, and 98% purity at ₹800/kg MOQ 5 kg—this is the primary cost reference.

Jeeva Organic (India-based, NOP certified) also supplies the exact grade but requires a custom quote. Pricing is directional and based on open-MOQ marketplace leads; confirm MOQ, delivery terms, and COA (HPLC charantin assay) with suppliers before purchase. Lead time is typically 5–7 days from Indian stock

Next Step: Confirm supplier quote, COA, freight, duties, lead time, and certifications before purchase.

Order quantity: 25 kg

Supplier leads (directional — confirm exact grade, MOQ, and COA):

Source Links:

GR Herbals

Jeeva Organic Private Limited

Charantin 10%-20% Bitter Melon Extract Powder Plant Extract

Amount Range: 83–133mg per capsule (250–400mg extract daily)

Benefit: Reduction of fasting plasma glucose, fasting insulin, and HOMA-IR in adults with impaired glucose regulation via oral supplementation. Complements Gymnema sylvestre leaf extract through complementary mechanisms — Gymnema stimulates insulin secretion from beta-cells while bitter melon improves peripheral insulin sensitivity and glucose uptake, together providing multi-target blood sugar regulation.

Ayurvedic Basis:

Momordica charantia is documented in the Charaka Samhita under the traditional names Karavella (larger

variety), Kathillaka (smaller variety), and Karavalli. The plant appears in classical therapeutic contexts for fever management (jvara). The Charaka Samhita states: 'Among pot-herbs the following are regarded as beneficial in fever, viz., the leaves of Trichosanthes dioica along with its fruit and stem, Papachelika

(otherwise called Karavella or Momordica charantia of the larger variety), Karkotaka (Alangium hexapetalum), and Kathillaka (Momordica charantia of the smaller variety).' Momordica charantia is classified among bitter pot-herbs (tikta rasavarga). In the classical dietary management section for prameha (urinary disorders), bitter pot-herbs are noted as suitable dietary components. The bitter taste (tikta rasa) possesses properties described in the Charaka Samhita as anthelmintic, destructive of fevers, promoting appetite, and assisting in digestion of undigested food. The plant's classical inclusion in fever management and prameha dietary contexts may relate to metabolic and urinary regulation, though the texts do not explicitly enumerate properties as a standalone ingredient.

Regulatory Compliance:

Scientific Basis: Mes et al. (2025, PMID 40199408) conducted two randomized controlled trials evaluating Momordica charantia supplementation in a prediabetic population. In Study 2 (n=38, parallel design, 12 weeks), freeze-dried bitter melon whole fruit at 3.6 g/day produced significant reductions in fasting plasma glucose (FPG, p=0.014), fasting insulin (p=0.007), and HOMA-IR

(p=0.003) versus placebo. Between-treatment analysis confirmed significant effects on FPG

(p=0.026) and HOMA-IR (p=0.045). On average, bitter melon reduced FPG by approximately 0.05 mmol/L per week. No adverse health effects were reported in either study. Study standardization:

Freeze-dried whole fruit powder with no standardization stated; typical charantin content in dried bitter melon fruit is approximately 0.1–0.3% by weight. Study bioactive dose: 3,600 mg/day × ~0.2%

charantin (midpoint assumption) ≈ ~7.2 mg charantin/day. Proposed ingredient: 10% charantin standardized extract at 300 mg/day (3 × 100 mg) 30 mg charantin/day. This delivers approximately 4× the conservatively estimated study bioactive dose; however, the standardized extract approach is well-supported in Ayurvedic practice and the 300 mg/day extract dosage is substantially lower than the 3,600 mg/day whole-fruit dose used in the study, keeping total capsule mass well within Size 0 capacity constraints. The higher charantin delivery from the standardized extract may be expected to produce effects at least comparable to the study outcomes. Kim et al.

(2020, PMID 32951763) further corroborates bitter melon extract efficacy in T2DM adults: a randomized placebo-controlled trial (n=90, 12 weeks) showed bitter melon extract significantly reduced average fasting glucose levels (p=0.014) with no serious adverse events, directly in the target population of adults with type 2 diabetes.

Primary Reference: 10.1016/j.jep.2025.119756

Additional Supporting Studies:

• https://doi.org/10.1016/j.metop.2025.100407 Momordica charantia efficacy meta-analysis in prediabetes/T2D hyperglycemia directly corroborates main study benefit.
• https://doi.org/10.7759/cureus.77806 Includes Momordica charantia and Gymnema sylvestre combination for hypoglycemic effects, matching main study's complementary mechanism claim.
• https://doi.org/10.1002/ptr.6853 Systematic meta-analysis of M. charantia in T2D animal models confirming insulin resistance reduction and glycemic control.
• https://doi.org/10.1016/j.biopha.2018.09.098 M. charantia saponins (charantin) reduce fasting glucose and insulin resistance in T2D mice, directly corroborating mechanisms.
• https://doi.org/10.1016/j.jaim.2018.05.004 RCT combining Gymnema sylvestre and Momordica charantia for prediabetes directly corroborates complementary multi-target mechanism.
• https://doi.org/10.1080/13880209.2017.1396350 M. charantia extracts ameliorate insulin resistance via SOCS-3/JNK pathway in T2D rats, supporting peripheral insulin sensitivity mechanism.
• https://doi.org/10.1016/j.jep.2016.10.043 Bitter melon improves insulin resistance via anti-inflammatory gut microbiota pathway in HFD rats, supporting peripheral sensitivity mechanism.
• https://doi.org/10.1016/j.fct.2014.04.008 Charantin-rich M. charantia extract reduces fasting glucose, improves insulin, and glucose tolerance in T2D mice.
• https://doi.org/10.1371/journal.pone.0062309 Bitter melon triterpenoids activate AMPK, increase GLUT4 translocation, improving glucose disposal — supports peripheral insulin sensitivity mechanism.

Corroborating Evidence: Backed by 6 additional studies

BATCH MANUFACTURING RECORD (BMR)

Rule 157, Schedule T — Drugs & Cosmetics Rules, 1945

• -DOCUMENT HEADER

• -SECTION 1 — VOLUMETRIC FIT VERIFICATION (PRE-FORMULATION ENGINEERING)

*Performed internally prior to BOM finalisation.*

Capsule Size 0 Internal Volume: 0.68 mL = 680 µL

Active Ingredient Volume Calculation (high-density granular grade, density = 0.75 g/mL):

Remaining Void Volume: 680 − 584 = 96 µL

Case Classification: CASE C — Active volume is 85.9% of capsule volume. Void volume of 96 µL is available for excipients.

Excipient Allocation (Corrected Densities):

*Note on Colloidal Silicon Dioxide density: Fumed silica (Aerosil 200 grade) has a tapped bulk density of approximately 0.05 g/mL (50 g/L) per Evonik Aerosil published technical data (minimum tapped bulk density). This is substantially lower than general mineral density assumptions and must not be conflated with dense mineral salts.*

*Note on Magnesium Stearate density: Pharmaceutical-grade magnesium stearate has a tapped bulk density of approximately 0.28 g/mL (conservative lower bound per published pharmaceutical literature and FDA QOS references). This value is used here as the conservative engineering assumption.*

Remaining void after excipients: 96 − 60.7 = 35.3 µL

Maximum MCC (density = 0.45 g/mL): 35.3 µL × 0.45 g/mL × 1000 = 15.9 mg maximum

Nominal MCC (Q.S.):6.5 mg — well within the 15.9 mg maximum, providing a comfortable headroom of 9.4 mg.

> Critical Note — Void Space Margin: The nominal MCC Q.S. of 6.5 mg sits comfortably within the 15.9 mg volumetric maximum. The tapped density specification of ≥0.75 g/mL applies to the individual high-density granular grade active ingredients as sourced (incoming material specification). The finished blend tapped density will be lower than 0.75 g/mL due to the inclusion of low-density excipients (MCC at 0.45 g/mL, SiO2 at 0.05 g/mL). The minimum required blend tapped density to achieve a 450 mg fill in a 680 µL capsule is 450 mg ÷ 680 µL = 0.662 g/ mL. Tapped density of the actual blend must be verified at ≥0.66 g/mL (target 0.68–0.72 g/mL) during pilot-scale manufacture before committing to full production. If measured blend tapped density falls below 0.66 g/mL, reduce

MCC Q.S. accordingly and adjust the acceptable fill weight range.

Final Fill Weight per Capsule: 438.0 + 2.5 + 3.0 + 6.5 (MCC nominal Q.S.) = 450.0 mg

*MCC is designated Q.S. to target fill weight of 450 mg. Actual MCC quantity shall be adjusted at production based on measured tapped density of the active blend.*

• -SECTION 2 — BILL OF MATERIALS (BOM)

Batch Size: 100,000 capsules

Target Fill Weight per Capsule: 450 mg

Target Batch Fill Weight: 100,000 × 450 mg = 45,000 g = 45.000 kg

Manufacturing Overage: 5% -> Overage mass = 2,250 g = 2.250 kg

Total Batch Input Weight (with overage): 47,250 g = 47.250 kg

*Note: % w/w values represent the formulation ratio and sum to 100.00%. Batch weights include 5% manufacturing overage.* 2.1 Active Ingredients

2.2 Excipients

> MCC Accounting Note: The total dispensed MCC of 682.5 g is allocated as follows: 525.0 g is used as the equalweight carrier in the Black Pepper Extract single-step premix (Step 8 — content uniformity verified by HPLC per Section 7.3); the remaining 157.5 g is reserved for the main blend Q.S. adjustment (Step 14). Total MCC consumed: 525.0 g (premix) + 157.5 g (main blend) = 682.5 g. This allocation is consistent with the BOM total and the Dispensing Table.

2.3 Capsule Shell

*Note: HPMC capsule shells are specified in preference to gelatin to align with the all-Ayurvedic/vegetarian positioning of this formulation and to avoid animal-derived materials. Standard-grade HPMC (not low-moisture grade) is appropriate here as the fill does not contain lyophilised biologicals.* 2.4 BOM Summary — Per Capsule and Batch Totals

Arithmetic Verification:

• Per capsule: 133.0 + 150.0 + 100.0 + 50.0 + 5.0 + 6.5 + 2.5 + 3.0 = 450.0 mg
• % w/w sum: 29.56 + 33.33 + 22.22 + 11.11 + 1.11 + 1.44 + 0.56 + 0.67 = 100.00%
• Batch weight: 47,250.0 g = 45,000 g target fill + 2,250 g (5% overage)
• -SECTION 3 — EQUIPMENT LIST

• -SECTION 4 — ENVIRONMENTAL CONTROLS
• Manufacturing Area Temperature: 18–25°C
• Relative Humidity: ≤40% RH during all blending, encapsulation, and packaging operations
• Rationale: The herbal extracts in this formulation are hygroscopic. Humidity above 40% RH will cause powder caking, reduced flowability, and inconsistent fill weights.
• Environmental Monitoring Logging Interval: Minimum every 15 minutes during all blending and encapsulation operations using calibrated data-logging instruments.
• Alert Limit: Temperature >27°C or RH >38%.
• Action Limit: Temperature >30°C or RH >40%.
• Action Required at Action Limit: Suspend manufacturing operations immediately. Investigate and correct environmental conditions. Resume only after conditions return within specification for ≥30 continuous minutes.

Document all excursions, duration, and corrective actions in the Batch Manufacturing Record.

• Cleanroom Classification: Class D (ISO 8) or equivalent, as per Schedule T requirements for solid oral dosage forms.
• Personnel: Full gowning (coverall, gloves, mask, hair net) required in all manufacturing areas.
• -SECTION 5 — MANUFACTURING INSTRUCTIONS 5.1 Pre-Processing: Incoming Material Verification

1. Verify that all incoming raw materials are accompanied by a Certificate of Analysis (CoA) from the approved

supplier. Confirm the following for each active extract:

• Identity (HPTLC fingerprinting matching the Ayurvedic Pharmacopoeia of India (API) monograph or approved inhouse reference standard)
• Assay of marker compound (gymnemic acids 25%; saponins 50%; charantin 10%; tannins/polyphenols 45%; piperine 95%) by HPLC
• Tapped density ≥0.75 g/mL (high-density granular grade confirmation — incoming material specification for individual active extracts only)
• Moisture content ≤5% (Karl Fischer or Loss on Drying)
• Heavy metals within AYUSH limits (Pb <10 ppm, As <3 ppm, Cd <0.3 ppm, Hg <1 ppm)
• Microbial limits: Total Aerobic Microbial Count (TAMC) ≤10^4 CFU/g; Total Yeast and Mould Count (TYMC) ≤10^2

CFU/g; absence of *Salmonella* spp., *E. coli*, *Staphylococcus aureus* per IP/API specifications

2. Quarantine and label all incoming materials as "UNDER TEST" until QC release.

3. Upon QC approval, re-label all materials as "APPROVED — RELEASED FOR USE" and transfer to the dispensing

area.

• -5.2 Dispensing

4. Verify that the manufacturing area temperature is 18–25°C and RH ≤40% before commencing dispensing. Log

readings.

5. Weigh all ingredients using calibrated scales as specified below. Two-person verification (weigher + checker) is

mandatory for all dispensing steps. Record all weights in the Dispensing Log.

Dispensing Table (Batch of 100,000 capsules + 5% overage):

• -5.3 Black Pepper Extract Premix Preparation (Single-Step Equal-Weight Premix)

*Black pepper extract constitutes 1.11% w/w of the fill blend. At 525 g in a 47,250 g batch, the dilution ratio is approximately 1:90. A single-step equal-weight premix with MCC as the inert carrier is performed to improve initial distribution before the premix is incorporated into the main batch. This procedure is a single-step premix and is not a multi-step geometric dilution. Content uniformity testing by HPLC (RSD ≤6.0% for piperine, per Section 7.3) is the primary control for homogeneity assurance in the finished blend.*

> Validation Requirement: Demonstrate RSD ≤6.0% for piperine content uniformity across ≥3 pilot batches before committing to full production.

6. Weigh 525.0 g of Black Pepper Extract (High-Density Granular, 95% piperine) using the analytical balance.

Transfer to a clean, dry, labelled stainless steel planetary mixer bowl.

7. From the total dispensed MCC allocation (682.5 g), weigh out 525.0 g MCC for use in the premix. Set aside the

remaining 157.5 g MCC for the main blend Q.S. adjustment (Step 14).

*MCC allocation check: 525.0 g (premix) + 157.5 g (main blend Q.S.) = 682.5 g total dispensed MCC. This is consistent with the BOM and Dispensing Table.*

8. Premix Step: Add the 525.0 g MCC to the 525.0 g Black Pepper Extract in the planetary mixer bowl. Mix at low

speed (20–40 RPM) for 3–5 minutes until visually uniform. Total premix mass = 1,050.0 g. Active concentration in premix = 525.0 g / 1,050.0 g = 50.0% active. This premix will be further diluted approximately 45-fold when incorporated into the main batch blend.

9. Label the premix container: "Black Pepper Extract Single-Step Premix — 525.0 g active in 1,050.0 g total (50.0%

active) — Batch [No.] — Date [Date]."

10. Retain a 10 g sample of the premix for in-process content uniformity testing (piperine assay by HPLC).

• -5.4 Sieving of Raw Materials

*Sieving is performed on individual ingredients BEFORE blending to de-lump. Post-blend sieving is prohibited to prevent particle segregation.*

11. Pass each of the following ingredients individually through a 40-mesh (425 µm) stainless steel sieve prior to

loading into the blender. Collect and record any oversize material retained on the sieve; if oversize material exceeds 2% of the ingredient weight, return the material for re-milling and re-sieve.

• Gymnema sylvestre leaf extract
• Fenugreek seed extract
• Bitter Melon fruit extract
• Triphala extract

12. Pass the following excipients individually through a 60-mesh (250 µm) stainless steel sieve:

• MCC (157.5 g reserved portion for main blend Q.S.)
• Colloidal Silicon Dioxide
• *Note: Magnesium Stearate is added last and is not sieved at this stage.*
• -5.5 Main Blend — Stage 1: Active Ingredient Blend

*All blending is performed in the V-Blender or Bin Blender. Confirm RH ≤40% and temperature 18–25°C before commencing. Log environmental readings at start and end of each blending stage.*

13. Load the following ingredients into the blender in the order listed below. Loading order follows the principle of

largest-to-smallest mass to promote initial distribution:

• Fenugreek seed extract (15,750.0 g) — load first
• Gymnema sylvestre leaf extract (13,965.0 g)
• Bitter Melon fruit extract (10,500.0 g)
• Triphala extract (5,250.0 g)
• Black Pepper Extract Single-Step Premix (1,050.0 g — containing 525.0 g active)

14. Add the reserved MCC Q.S. (157.5 g nominal; weigh and record actual quantity added). The target is to bring the

total blend weight to the calculated batch input weight of 47,250.0 g. Verify total loaded weight. Record actual MCC

Q.S. weight added.

*Total loaded weight check: 15,750.0 + 13,965.0 + 10,500.0 + 5,250.0 + 1,050.0 + 157.5 + 262.5 (SiO2, added in Stage 2) + 315.0 (Mg Stearate, added in Stage 3) = 47,250.0 g *

15. Blend at 10–15 RPM for 15–20 minutes.

16. Collect a 20 g sample from three locations within the blender (top, middle, bottom) using a sampling thief.

Submit samples to QC for blend uniformity assessment (gymnemic acid assay by HPLC). Proceed to Stage 2 only upon confirmation of blend uniformity (RSD ≤5.0% for gymnemic acid content across the three samples).

• -- 5.6 Main Blend — Stage 2: Glidant Addition

17. Add the pre-sieved Colloidal Silicon Dioxide (262.5 g) to the blender.

18. Blend at 10–15 RPM for 5–10 minutes.

18A. After glidant blending, collect a 5 g sample from the blender discharge port. Perform visual inspection for uniform distribution of Colloidal Silicon Dioxide (no visible white clumps or segregation). Record observation in the Batch Manufacturing Record. Proceed to Stage 3 (Lubricant Addition) only upon satisfactory visual check. *Note:

Quantitative blend uniformity assay is not required at this stage as the glidant is a non-active excipient; visual confirmation is sufficient per GMP.*

• -5.7 Main Blend — Stage 3: Lubricant Addition (Final Step)

*Magnesium Stearate is added last. Blending time must not exceed 3 minutes after lubricant addition to prevent hydrophobicity and dissolution failure.*

19. Weigh Magnesium Stearate (vegetable-derived): 315.0 g. Pass through a 60-mesh sieve directly into the

blender.

20. Blend at 10–15 RPM for exactly 2–3 minutes. Do not exceed 3 minutes.

21. Stop blending. The final blend is now ready for encapsulation.

22. Collect a 20 g sample of the final lubricated blend from three locations (top, middle, bottom) using a sampling

thief. Submit to QC for:

• Final blend uniformity (gymnemic acid assay, HPLC; RSD ≤5.0%)
• Bulk density and tapped density measurement (confirm tapped density of finished blend ≥0.66 g/mL; target 0.68–0.72 g/mL)
• Flow rate (angle of repose ≤35°)

23. Transfer the final blend to labelled, sealed HDPE drums with desiccant sachets. Label: "Final Blend — Batch

[No.] — Date — APPROVED FOR ENCAPSULATION." Store at 18–25°C, RH ≤40% until encapsulation.

• -5.8 Encapsulation

24. Set up the automatic capsule filling machine for Size 0 HPMC capsule shells. Verify machine settings:

• Capsule size: Size 0
• Target fill weight: 450 mg per capsule
• Acceptable fill weight range: 436–464 mg (±3.0% of target)
• Machine speed: Set per manufacturer's recommendation for the blend's flow characteristics; adjust as needed based on in-process fill weight checks.

25. Load HPMC Size 0 capsule shells (empty) into the capsule hopper. Confirm shell specification (HPMC, moisture

3–6%, Size 0) matches the approved CoA.

26. Load the final blend into the powder hopper. Confirm RH in the encapsulation area is ≤40%.

27. Perform a start-up check: Fill and weigh the first 20 capsules individually. All 20 must fall within the 436–464

mg range before commencing full production run. If any capsule falls outside this range, adjust machine settings and repeat the start-up check.

28. During the production run, perform in-process fill weight checks at the following frequency:

• Every 30 minutes: Weigh 10 capsules individually. Record weights. All 10 must be within 436–464 mg. If ≥2 capsules fall outside the range, stop the machine, investigate, adjust, and repeat the start-up check before resuming.
• Every 2 hours: Weigh 20 capsules individually and calculate mean and RSD. Mean must be 450 ± 9 mg; RSD

≤2.0%.

29. Collect a sample of 100 capsules at the beginning, middle, and end of the production run for QC testing (see

Section 7).

30. Record total number of capsules filled, number rejected by checkweigher, and number of capsule shell defects

observed.

• -5.9 Capsule Polishing

31. Pass all filled capsules through the capsule polishing machine to remove surface powder.

32. Visually inspect polished capsules for gross defects (open capsules, deformed shells, visible powder leakage).

Remove and record all defective units.

• -5.10 In-Process Yield Calculation

33. Calculate in-process yield:

• Theoretical Yield: 100,000 capsules (target commercial output, excluding manufacturing overage). *Note: 5% overage (5,000 additional capsules) is included in batch input to account for machine start-up, in-process sampling, and rejects. Yield % is calculated against the 100,000-capsule commercial target only, not against the 105,000-capsule input quantity.*
• Actual Yield: Total capsules filled − rejected capsules
• Yield %: (Actual Yield / 100,000) × 100
• Acceptable Yield: ≥95.0% (i.e., ≥95,000 capsules of the 100,000-capsule commercial target)
• If yield falls below 95.0%, investigate cause before proceeding to packaging.
• -SECTION 6 — PACKAGING 6.1 Primary Packaging

34. Package finished capsules in one of the following primary packaging configurations (as per approved

packaging specification):

• Option A: HDPE bottles (60 capsules per bottle) with induction-sealed aluminium foil liner, child-resistant cap, and desiccant sachet (1 g silica gel per bottle).
• Option B: Aluminium-aluminium blister packs (10 capsules per blister strip; 6 strips per carton = 60 capsules per carton).

35. For HDPE bottles: Verify torque of child-resistant cap (target: 15–20 N·cm). Verify induction seal integrity

(visual inspection: no bubbles, complete seal).

36. For blister packs: Verify seal integrity by visual inspection and peel test on 5 blisters per batch.

6.2 Labelling Requirements (Schedule T / AYUSH)

37. Each primary container label must include:

• Product name
• "Ayurvedic Proprietary Medicine"
• Composition (Sanskrit names and botanical names of all five herbal extracts with part used and standardisation)
• Net quantity (e.g., "60 Capsules")
• Dose: "1 capsule three times daily or as directed by the physician"
• Mfg. Lic. No. [State Code]-XXXX
• Batch No., Mfg. Date, Expiry Date (36 months from Mfg. Date)
• "Store in a cool, dry place below 25°C. Keep away from direct sunlight."
• "Keep out of reach of children."
• Mandatory Safety Statement: "Persons taking antidiabetic medications (e.g., metformin, sulfonylureas, insulin) should consult a registered physician before use and monitor blood glucose levels closely. This product contains piperine, which may enhance the bioavailability of co-administered medications."
• Manufactured by: [Company Name, Address, Mfg. Lic. No.] 6.3 Secondary Packaging

38. Pack primary containers into secondary cartons. Include a package insert with full composition, indications,

dosage, contraindications, drug interactions warning, and storage instructions.

39. Seal secondary cartons and apply tamper-evident labels.

40. Pack secondary cartons into shipping cases. Label shipping cases with batch number, quantity, storage

conditions, and handling instructions.

• -SECTION 7 — QUALITY CONTROL SPECIFICATIONS 7.1 Organoleptic Evaluation (Mandatory — Schedule T)

7.2 Physical Parameters

7.3 Chemical / Assay Parameters

*Note: Visual inspection is insufficient for piperine (1.11% w/w) and all other low-dose actives. Quantitative HPLC assay is mandatory.* 7.4 HPTLC Fingerprinting (Identity — AYUSH Mandate) 7.5 Heavy Metal Limits (AYUSH Parameters)

*Method: ICP-MS or AAS per IP/API specifications. Test on finished product (composite of 10 capsules, fill powder only).* 7.6 Microbial Limits

*Method: IP/API microbiological methods.* 7.7 Packaging Integrity

• -SECTION 8 — STABILITY REQUIREMENTS
• Statutory Shelf Life: 36 months from date of manufacture (Rule 161-B, Schedule T, Drugs & Cosmetics Rules, 1945).
• Stability Study Protocol: Conduct accelerated stability studies at 40°C ± 2°C / 75% RH ± 5% RH (ICH Q1A) and long-term stability studies at 30°C ± 2°C / 65% RH ± 5% RH (ICH Q1F Zone IVb, applicable to India).
• Stability Test Intervals: T=0, 3, 6, 9, 12, 18, 24, 36 months (long-term); T=0, 3, 6 months (accelerated).
• Stability Parameters to Monitor: Appearance, fill weight, disintegration, gymnemic acid assay, piperine assay, charantin assay, tannin assay, saponin assay, microbial limits, moisture content.
• Acceptance Criteria: All parameters must remain within the specifications defined in Section 7 throughout the shelf life.
• -SECTION 9 — STORAGE CONDITIONS
• Finished Product: Store below 25°C in a cool, dry place. Protect from direct sunlight and moisture.
• Intermediate Blend (pre-encapsulation): Store in sealed HDPE drums with desiccant sachets at 18–25°C, RH

≤40%. Maximum hold time before encapsulation: 72 hours. If hold time exceeds 72 hours, re-test blend uniformity and moisture content before proceeding.

• Raw Materials: Store as per individual CoA requirements. All herbal extracts to be stored in sealed containers at 15–25°C, RH ≤40%, protected from light.
• -SECTION 10 — SAFETY NOTES AND REGULATORY STATEMENTS
• Drug Interaction Warning: This formulation contains five herbal agents with documented blood-glucose-lowering activity (Gymnema sylvestre, Fenugreek, Bitter Melon, Triphala, Black Pepper/piperine). Additive hypoglycaemic effects are possible when co-administered with antidiabetic medications. Patients on antidiabetic medications must consult a registered physician before use and monitor blood glucose closely to avoid hypoglycaemia.
• Piperine Bioavailability Enhancement: Piperine (from Black Pepper extract) inhibits CYP3A4 and P-glycoprotein, potentially enhancing the bioavailability of co-administered drugs including antidiabetic agents. This interaction must be disclosed on the product label.
• Daily Piperine Intake: At 3 capsules per day, total daily piperine intake is approximately 14.25 mg/day. This formulation is positioned as an Ayurvedic herbal supplement under AYUSH regulations (India), where *Marica*

(Black Pepper) is a classical co-ingredient. Manufacturers targeting EU markets should review applicable national regulations (e.g., BfR guidance) and adjust labelling or dosage accordingly.

• Pregnancy and Lactation: Safety in pregnancy and lactation has not been established. Use is not recommended without physician supervision.
• AYUSH Compliance: This product is manufactured as an Ayurvedic Proprietary Medicine under Schedule T of the Drugs & Cosmetics Rules, 1945. All five herbal ingredients are approved under AYUSH regulations based on authoritative Ayurvedic classical texts.
• -SECTION 11 — BATCH RECORD SIGN-OFF

• -*This Batch Manufacturing Record has been prepared in accordance with Rule 157, Schedule T, Drugs & Cosmetics

Rules, 1945, and applicable AYUSH Good Manufacturing Practices. All manufacturing operations must be performed by trained personnel under the supervision of a qualified Ayurvedic Pharmacist or registered practitioner as required by the applicable State Licensing Authority.*