In its preoccupation with vegetarianism, the Ministry of Health and Family Welfare seems to have disregarded some key practical concerns while proposing a blanket switch to vegetarian medication for Indians. Needless to say, India's pharmaceutical industry is not pleased.
In March this year, the Health Ministry set up an expert committee to look into its proposal of replacing gelatin capsules with plant-based cellulose ones as a matter of urgent priority. The committee had issued a notice dated June 2, inviting suggestions and comments from all stakeholders — consumers, manufacturers, marketeers and NGOs — on the proposal.
The Telegraph reported yesterday that The Punjab Haryana Delhi (PHD) Chamber of Commerce has called the proposal impractical. "This proposal to replace gelatin capsules is totally misplaced and uncalled for — this is possibly a political move that unwisely brings the issue of vegetarian and non-vegetarian into drugs," Vivek Seigell, director of the PHD chamber, was quoted as saying to The Telegraph.
Several industry experts have expressed safety and cost concerns as well. According to a report on Pharmabiz.com, gelatin capsules have been in use for the past 185 years and have been approved globally reputed agencies such as the US Food and Drug Administration, UK's Medicines and Healthcare products Regulatory Agency, the European Union and many others after extensive clinical trials. Cellulose capsules will have to undergo years of testing before they can be released in the market.
According to a report in Indian Express, The Drug Controller General of India (DCGI) GN Singh himself admitted to KL Sharma, Joint Health Secretary in an email that no standard for a vegetable capsule was prescribed in the Indian Pharmacopoeia (an official list of drugs, their formula and other related information) and that such capsules would be 2.5 to 3 times costlier than their gelatin counterparts.
A New Indian Express report quoted M Rajarathinam, former president of the Indian Drug Manufacturers Association, Tamil Nadu as saying, "On one side, the Central government says reduce medicine prices. But cellulose-based capsules would cost four times more than gelatin-based ones, as the component is derived from animal waste, whereas cellulose is extracted from plants or seeds, depending on manufacturers."
Given that affordable healthcare has been a major policy pillar for the current Modi government, with the Centre planning to make it legally mandatory for doctors to prescribe generic and not branded drugs, among other promised initiatives, one can only wonder if driving up the cost of medication in the name of vegetarianism is a justifiable move.
The issue of vegetarian pills was first raised by Women and Child Development Minister, Maneka Gandhi in March 2016, in a 'representation' to the Union Health Minister JP Nadda. Gandhi claimed that "In a country where there are millions of vegetarians, this hurts religious sentiments and many people avoid medicines that are in capsule form."
The initial proposal was to label gelatin capsules with a red dot and plant-based ones with a green one. But it was shot down in May last year by the country's apex drug committee, the Drug Technical Advisory Board (DTAB), saying that unlike food, drugs are not taken by choice, that doctors prescribe them to save lives and marking them as vegetarian or non-vegetarian origin is "not desirable," according to the minutes of a DTAB meeting held on May 13.
A fortnight later, the Health Ministry modified the proposal to using cellulose instead of gelatin in capsules. The DCGI claimed that cellulose-based capsules had three advantages: vegetable capsules were preferable in a vegetarian society, no cross-linking reaction, unlike in the case of gelatin capsules and its suitability in moisture-sensitive products.
At present, 95 percent of capsules in the world use gelatin to wrap the drug formulation, and 98 percent of the Indian pharma industry uses it as well. If the proposal is implemented, the move will severely affect India's Rs 5,000-crore capsule industry.Suggest a correction