The expert panel said the shift to cellulose capsules from gelatin capsules is not recommended at the this time, and left any such decision to drug manufacturers
New Delhi: In a big relief to the pharmaceuticals industry, an expert panel has nixed a proposal by women and child development minister Maneka Gandhi to make it mandatory to replace widely used animal parts-based gelatin capsules with vegetarian capsules made from cellulose.
In a report submitted to the Union health ministry, the experts said compulsory and mandatory replacement of capsules was not “recommended" at this time, and left the decision of switching over to cellulose capsules entirely to manufacturers.
The committee, set up by the government in March 2017 under C.K. Kokate, submitted its report in December. “It is the prerogative of the manufacturer to use either of the capsules for encapsulation of the drugs depending on the technical as well as the regulatory requirements based on the nature of the drugs," the panel said in its report. Additionally, the panel has recommended against labelling the capsules with red and green dots to indicate their origin in the interest of the patients.
“Drugs unlike food are not taken by choice of the patients, but are prescribed by physicians. Labelling these drugs as vegetarian or non-vegetarian is not desirable," it said.
It also said that the contents of the capsules may also contain drugs which are not of vegetable origin, adding that labelling of drugs would lead to their non-acceptance by some patients who are vegetarians and “this is not desirable in the interest of the patients".
Currently, 98% of the Indian pharmaceutical industry uses animal parts-based capsules although the government has been pitching for “vegetarian capsules".
The health ministry had received a representation from Gandhi seeking replacement of gelatin-based capsules with plant-based ones. The ministry had set up an expert committee in March 2017 to address the issue.
According to the panel, cellulose-based capsules would be “significantly" costlier than gelatin capsules. “The manufacturers will again be required to conduct stability as well as bio-equivalence studies for complying with regulatory requirements. Further the cellulose based or HPMC capsules may require change in dosage due to possibility of differences in dissolution pattern and onset of action which is not desirable," it said. Mint has reviewed the report.
The experts also raised concerns over the safety of cellulose-based capsules. “The safety of gelatin capsules is already established and these capsules are used worldwide for encapsulating the drug components. According to the technology available worldwide soft gelatin capsules cannot be manufactured by using by cellulose based material. Drugs belonging to narrow therapeutic index would require more vigorous bridging studies to ensure safety and efficacy," the report said.
A move to cellulose-based capsules would also increase India’s dependence on Chinese companies for supply of raw materials, the panel said. “There is a problem of machinability and availability of technology in the country for manufacturing of cellulose-based capsules in such huge volume. There will be a huge dependency on other countries for importing the raw material as presently all the raw material is being imported mainly from China," it said.
Gelatin is obtained from processed bones, skin and tissue of pigs, cattle and other animals. On the other hand, cellulose capsules are of synthetic origin. Interestingly, cellulose capsules are not used for allopathic medicines but only for nutraceuticals and herbal medicines. At present, they form less than 2% of the total production of capsules.
According to the Indian Drugs Manufacturing Association, the consumption of gelatin capsules in India is about 120 billion a year, compared with just 2 billion cellulose capsules.
According to the committee, commerce ministry representatives too have rejected the proposal, citing adverse impact on exports.
“It will affect the exports markets as it will require re-registration of their cellulose capsule-based products in exporting countries which may take considerable time of few years," it said.
However, the committee said if a manufacturer or another entity wants to develop and launch any product in cellulose-based capsules, it is free to do so. “Further efforts for the development of technology of manufacturing cellulose capsules may be encouraged," it said.
Earlier in 2016, the government’s top advisory board on drugs, the Drugs Technical Advisory Board, had disagreed with a proposal to mark vegetarian capsule packs with a green dot. Also, the Supreme Court had ruled in 2013 that it was not desirable to label lifesaving drugs as vegetarian or non-vegetarian, adding that it should be left to the doctors to decide what was appropriate for a patient.
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