Government's plan to replace animal parts-based gelatin capsules with cellulose-based ones has received a setback as an expert panel formed to look into the matter reported against the proposal.
According to LiveMint, which has accessed the report, the panel has informed the health ministry that the replacement was not "recommended" at this time and asked the decision to be left entirely on manufacturers.“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 daily quoted from the report.
The panel has reportedly also nixed the proposal to label capsules with red and green dots to indicate their origin in the interest of the patients. They said as the drugs unlike food are not taken by choice of the patient, labelling of drugs as vegetarian and non-vegetarian is not desirable.
As reported in June, the proposal was put forward by union minister for women and child development Maneka Gandhi citing religious sentiments. "In a country where there are millions of vegetarians, this hurts religious sentiments and many people avoid medicines that are in capsule form. Representations received from the Jain community have also requested that since there is an option available in the country, consumers must not be forced to use capsules made from animal tissue," Gandhi's representation to the health ministry had said.
The report has come as a big relief to the pharmaceutical industry that has been against the idea since the beginning.
Reasons cited by the industry range from cost to international approvals. Gelatin capsules have been in use for more than 185 years and are approved by the US Food and Drug Administration, UK's Medicines and Healthcare products Regulatory Agency, the European Union, among others. Currently, 98% of the Indian pharmaceutical industry uses Gelatin capsules.
The expert panel has cited similar concerns while recommending against the proposal. The report says that cost of cellulose-based capsules would be "significantly" higher than gelatin capsules. Other reasons stated include: stability and bio-equivalence studies by manufacturers for complying with regulatory norms, change in dosage due to differences in dissolution pattern and onset of action, non-availability of raw material in India. "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," report said.
The committee also raised safety issues in the report. "Drugs belonging to narrow therapeutic index would require more vigorous bridging studies to ensure safety and efficacy,” report said.