DCGI mulls alternatives to China active pharmaceutical ingredients
MUMBAI: The Drug Controller General of India (DCGI) has got local drugmakers to draw up an emergency plan on dealing with any blockade on shipments from China of active pharmaceutical ingredients (APIs), or raw materials used to make medicines, in the event of border tensions escalating. Indian companies get most of their APIs from China.
A meeting last month had discussed how India could be prepared in a “worst-case” scenario that could lead to a scarcity of imported APIs, said a senior government official. “The government has identified important therapeutic segments for which molecules are (mostly) imported (from China),” said the official. The meeting was attended by various industry association groups of both multinational and Indian drug makers. “The agenda of the meeting was to understand what measures the government could take to support the domestic industry and encourage it to manufacture these products.”
The Indian Drug Manufacturers Association (IDMA), a lobby group of domestic pharma firms, recently submitted a six-page action plan listing various measures that the Indian government should implement to reduce dependence on APIs from China. ET has seen a copy of this.
Steps Proposed by Industry Lobby
This includes higher registration fees on imports and increased inspections of APIs from China. It has also asked the government to explore alternative sources for raw materials, especially essential therapies such as anti-infective drugs. Additionally, it has suggested the revival of state-owned units such as Hindustan Antibiotics that can produce essential raw materials in an emergency.
“At present India is not able to manufacture many important drugs due to low-priced imports from China. In order to be ready for any future emergency, we need to have at least some capacities created for a few of the drugs which are identified as essential for the country. In this way, in case of any emergency, all that we need to do is to increase capacity of the same in a short time,” IDMA said in the letter to the drug controller. “We should further ensure that companies are advised to maintain three-six months stock of APIs/intermediates that are imported from China.” There was no response to emails sent to the DCGI on Monday. IDMA didn’t respond to queries.
India imports about 84% of the APIs it needs, according to officials in the Central Drugs Standard Control Organization. It got APIs worth Rs 13,853 crore from China in FY16, or 65.3% of the Rs 21,217-crore total. This included ingredients for essential antibiotics.
Industry groups have suggested the government enter into agreements with friendly nations for supply of key medicines and APIs in the categories specified above.
“There is a concern that if the tensions continue over the border issue, this will hit pharma sector and it is worrying because we do not even have the API capacity to manufacture a paracetamol,” said an executive who was at the meeting mentioned above.
“But because Indian companies do not have any support from the government to produce APIs, we are losing out to China.” Though India is a leader in finished generic drugs, China is a preferred source for APIs because of price.