New Delhi: Indian drug makers have sought the intervention of the Prime Minister’s Office (PMO) against a recently floated government proposal to replace the widely used animal parts-based gelatin capsules with those derived from cellulose.
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.
But the industry is worried about its potential impact.
Arguing that the replacement of hard gelatin capsules is “totally uncalled for", representatives of drug makers took up the matter with the principal secretary in the PMO Nripendra Misra recently.
They said the change from gelatin to cellulose capsules will not benefit consumers and will make a dent in the government’s dream of making healthcare affordable.
The experts also raised their concerns with the ministry of health and family welfare and the Drug Controller General of India (DCGI), stating that the move will increase dependence on Chinese companies for cellulose and raw materials.
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.
Vegetarian capsules have been backed by Women and Child Development minister Maneka Gandhi.
In 2016, the Drugs Technical Advisory Board (DTAB) had disagreed with a proposal to mark vegetarian capsule packs with a green dot.
Similarly, 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. However, the issue came to the fore again in September when DCGI formed the expert committee.
Gelatin is obtained from processed bones, skins and tissues of pigs, cattle and other animals. On the other hand, cellulose capsules are of synthetic origin.
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 of making healthcare 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.
Interestingly, cellulose capsules are not used for medicines.
They are only used for nutraceuticals and herbals and, at present, form less than 2% of the total production of capsules.
According to the Indian Drugs Manufacturing Association (IDMA),the consumption of gelatin capsules in the country is about 120 billion every year compared with just two billion cellulose capsules for the same period.
“No one knows the effects of cellulose on medicines. It has to be tested over two-to-three years through the life of a medicine. Both cellulose and gelatin should co-exist and the choice should be left to the patients and the doctors prescribing them," said another expert from the drug industry.