India's national government is busy laying plans to create a stand-alone ministry for pharmaceuticals and medical devices by the end of next year, increase regulation of online drugs and boost API production. But all is for naught if products cannot get out the door.
The head of the Chemicals and Fertilisers Ministry that now has responsibility for drug and device regulation is laying bets that the healthcare products will be out his door and on its own a year from now, according to the Business Standard newspaper.
"I assure you in (the) next one year it will emerge as a separate entity as pharma and medical devices ministry," Ananth Kumar said, according to Business Standard.
A flurry of reports on all of these subjects came as Kumar updated the local press on progress-to-date in his ministry and what may lie ahead for the overall pharma and medical device industries.
On another subject, he said that within 100 days, India will be less reliant on China for its bulk drugs (active pharmaceutical ingredients) as it implements an advisory panel's recommendations for helping build domestic makers.
On another issue Kumar said the government was considering creation of industrial parks for makers of devices and bulk drugs. Elsewhere, the government has formed a panel to study online drug sales.
As Kumar and other government officials addressed an annual conference of pharmaceuticals and medical devices, the Associated Chambers of Commerce and Industry of India (ASSOCHAM) issued a study showing makers may not be able to export them any faster with those changes.
The group, Business Standard noted, said India has more than 10,000 drug-production facilities, but only 1,500 inspectors to see that they meet international standards, an area in which the country has lagged, causing many other nations, particularly the United States and Europe, to ban its products from their shores.
The study blamed in part India's complex regulatory system in which responsibility is divided among several agencies with varying regulations, particularly in the area of patents where dozens of offices scattered around the country do not follow the same procedures.
The study also laid some of the blame on drug makers themselves, saying companies are poorly manned and poorly led when it comes to following regulations that in turn affect the quality of their products. On top of that, small and medium-sized companies lack the capacity to do their own quality checks, it said. Government subsidies for the companies are available only if they are located in economic zones.
On that subject, Kumar said the government has accepted a panel's suggestion that separate zones be established dedicated to drugs and devices makers, a move he said could reduce manufacturing costs by 30% for what he termed India's "sunshine industry."
Speaking separately about changes in the bulk-drugs policy, Pharmaceutical Secretary V.K. Subburaj said he expected the new policy to be finalized next week. He said the government would also consider a reduction in the 12% interest rates faced by API manufacturers, making them more competitive with China's 5% rate.
Meanwhile, the Drug Controller General of India, online news portal medianama updates, has formed a seven-member panel to examine online sales of drugs to consider health and safety issues as well as pharmacist calls for a total ban on such sales.
- here's the story from medianama
- and one from domain-b
- here's an article from Business Today
- and one from Business Standard on the ASSOCHAM study
- and another one from Business Standard on Ananth Kumar