Animal parts based capsules are used by nearly 98% of the Indian pharmaceutical industry. Capsules are made from Gelatin which is mostly animal proteins obtained by processing animal bones, hoofs and connecting tissues of various animals. Once the animal parts (such as bones, tissues) are processed then the product obtained is a gel like substance which is tasteless, odorless and colorless. This gel is then allowed to cool in cold water and expanded further to produce Gelatin.
Many communities in India would not like to consume these capsules made from Gelatin as its origin is animal protein. Vegetarians do not consume animal products in any form, also due to religious beliefs and cultural norms.
Gelatin Replacement Proposal
The proposal to replace all the Gelatin based capsules with Cellulose based capsules was initiated by Maneka Gandhi (Union Minister for Women and Child Development). But the industry is uncomfortable with this proposal as potential impact of this move is yet to be analyzed effectively.
ARAP raised concern with Expert Committee of “Ministry of Health and Family welfare”.
Association of Regulatory Affairs Professionals (ARAP), a registered National level non-profit society for the Regulatory Affairs Professionals and listed as Organizational member of Quality Council of India, Govt. of India has written to Ministry of Health & Family welfare regarding the technicalities and potential impacts that needs to be addressed first before moving further to replace gelatin based capsules.
According to ARAP letter, drugs are not taken by choice but are prescribed by the doctor to save lives. Distinguishing drugs as vegetarian or of non-vegetarian origin is not desirable. Hydroxypropylmethyl cellulose (HPMC) capsule is of synthetic origin and it cannot be considered purely vegetarian origin.
Supreme Court also ruled in 2013 that labeling medicines as Veg or non-veg is not acceptable. Similarly Drugs Technical Advisory Board (DTAB) also unaccepted the proposal to mark green and red dot over medicine packs.
Technical Aspects raised by ARAP
Cellulose cannot be used in the manufacture of soft cellulose because of their inherent properties and if the gelatin capsule is stopped in the country, raw materials for cellulose capsules will have to be imported which is against the ‘Make in India’ policy
Cellulose is an insoluble fiber and human body does not have enzymes to digest and will lead to side effects such as blotting, diarrhea etc.
If the drug is encapsulated in Cellulose based or HPMC Capsules, Pharmacodynamics and Pharmacokinetics properties of the drug has to be tested before it is put in to the market
Replacing gelatin based capsules with cellulose based capsules in Pharma industry would require major reviews of existing formulations including fresh stability studies to demonstrate the compliance requirement
Regulatory Aspects raised by ARAP
- As per Drugs and Cosmetics Act 1940 and Rules 1945 change in dosage form would be consider as New drugs for that every formulation has to get necessary regulatory permission from regulatory authorities.
- Requirement of studies like compatibility studies, toxicity-bridge and performance-bridge through dissolution /bioavailability/clinical studies.
- These studies would be needed not only in the ‘initial’ product cycle but also at the end of the shelf life.
Recommendations by ARAP
- As per current scenario, there is no proper beneficial justification to consider the proposal to switch from well tested and proven technology of gelatin based capsules to non-gelatin (HPMC based) capsules
- First we need to increase the production capacity of HPMC capsules with minimum cost.
- Secondly, we have to prepare regulatory guidelines and start study on safety and stability of HPMC capsules
Expert committee formed by Government.
Expert committee constituted under Prof. C.K. Kokate, vice-chancellor of KLE University, Karnataka to review the proposal and its impact. In the latest Expert committee meeting held on 20th Nov, the various aspects of both Gelatin and HPMC (Cellulose) were discussed by ARAP and other stakeholders namely Beauty without cruelty, Boehringer Ingelheim India Pvt Ltd., Fortcaps Healthcare Limited, along-with representative from Gelatin manufacturer of Europe and Indian Medical Association.
If the drug is encapsulated in Cellulose based or HPMC Capsules, Pharmacodynamics and Pharmacokinetics properties of the drug has to be tested before it is put in to the market.
If the Gelatin capsule is stopped in the country, raw materials for cellulose capsules will have to be imported which is against the ‘Make in India’ policy.
Also, Replacing Gelatin based capsules with cellulose based capsules in Pharma industry would require major reviews of existing formulations including fresh stability studies to demonstrate the compliance requirement.
Further, as the cost for cellulose based capsules is high, its encapsulation by the pharmaceutical industry will be challenging especially in light of the Drugs price controls being implemented by the Govt. of India (NPPA) under Drugs price control order.
- Shortage of medicine if replacement ordered
- Increase cost of medicine
- Safety and stability of approved medicine again tested
- Extra burden on industry
- Due to less supplier depends upon import of raw materials
- Major regulatory reform on oral dosage form
Based on the meetings, Expert committee is believed to submit its report in next 1-2 months. It is believed that this proposal will be put on hold as there are lots of technicalities with this proposal which is yet to be analyzed. Without full preparation taking such huge decision will completely disrupt the Indian health and pharmaceutical sector with shortage of medicines and unbearable price hike.