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Drug Firms Urge PMO to Intervene against Gelatine Capsule Replacement

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, had, in April last year, received a proposal from an advisory panel looking into the drug and pharmaceutical matters regarding the switch to cellulose-based “vegetarian” capsules, replacing the widely-used, animal-based gelatin capsules.

Currently, 98% of the Indian pharmaceutical industry uses animal parts-based capsules and the government has been pitching for ‘vegetarian capsules’ for the past two years.

A proposal has been received to replace gelatin capsules with cellulose-based capsules which are of plant origin and are safe for use compared to animal-based gelatin capsules. In order to examine the pros and cons of the proposal, we have invited science-based suggestions and comments for taking a considered decision on the matter,” Dr. GN Singh, Drug Controller General of India had said.

Bureau of Indian Standards (BIS) has also claimed that the cross-linking of gelatin and drug incompatibilities and the strict regulations regarding the use of animal-derived gelatin requiring the absence of bovine spongiform encephalopathy (BSE) (commonly known as mad cow disease, a fatal neurodegenerative disease in cattle that causes a spongy degeneration of the brain and

spinal cord) have encouraged the search for gelatin replacement.

In the recent era, vegetable capsules are the new approach and might replace the use of gelatin or non-vegetable capsules. Modified naturally occurring polymer cellulose is considered safe for normal consumption in humans. Hydroxypropyl methylcellulose (HPMC), most commonly known as hypromellose, is mainly used in the manufacturing of such kind of capsule shell. Most of the pharmaceutical capsules available in the market are made of gelatin; however several HPMC capsules for powdered herbs and dietary supplements have come up in recent years, the BIS said. BIS also said religious, cultural and personal issues may affect patients’ preference towards the medications presented in capsule dosage forms.

But now, the pharmaceutical industry has sought the intervention of Prime Minister’s Office (PMO) to resolve this long pending issue.

Pharmaceutical industry bodies viz. Indian Drug Manufacturers’ Association (IDMA), Ph.D. Chamber of Commerce and Industry (PHDCCI) called on the principal secretary to PMO Nripendra Mishra recently in New Delhi and apprised him of disadvantages and infeasibility of changing over from gelatin capsules to cellulose capsules. They appealed to Mishra to intervene and let pharmaceuticals and medicines be developed totally on a scientific basis and not on sentiments.

The government had in September formed an expert committee under the vice-chancellor of KLE University, Belgaum, Karnataka, Prof. C.K. Kokate, to look into the issue.

The panel has been having discussions with various stakeholders.

We have been interacting with all the stakeholders and working very carefully on the issue. The report is expected in the next 2-3 months,” Kokate said.

IDMA secretary general Dara Patel in the representation to Mishra stated that gelatin capsules have been in use for over 100 years. It has been found to be very safe for human consumption and accordingly it has been accepted by regulators all over the world. Thousands of crores have been spent on establishing the quality, viability, and economics of gelatin capsules. There have been no adverse reports of gelatin capsules.

We are totally self-sufficient with the raw materials for gelatin capsules. We will be totally dependent on imports of raw materials for cellulose capsules. The safety and efficacy of cellulose capsules cannot be guaranteed. Members are concerned that even after approvals, few long-term studies may show adverse reports and they may not want to take the responsibility for that. Today we manufacture 120 billion gelatin capsules compared to only 2 billion cellulose capsules. Cellulose capsules are 2-3 times expensive compared to gelatin capsules. This would increase the cost of drugs to the patients. Huge investment in plant and machinery would be required to adopt cellulose capsules,” Patel said.

According to industry experts, if implemented, the change-over will result in medicines becoming dearer.

Cellulose costs 3-4 times more than gelatin. To shift to cellulose, huge investments will be required in plants and machinery, which is most likely to hit the prices of medicines and will jeopardize the government’s move to making health care affordable,” said an industry expert on condition of anonymity.

Drug manufacturers are also concerned about sourcing raw material.

While the active pharmaceutical ingredient (API) dependence is already a huge cause of concern, according to industry experts, ushering major changes such as these will further increase dependence on Chinese imports.

Mishra considering views of the industry representatives finally agreed that both types of capsules should co-exist.

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