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The Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA) has said that it is time the industry and government team-up to list down the top 10 most critical active pharmaceutical ingredients (APIs) needed in the country like Penicillin G, Paracetamol, Vitamin C, etc. These should be on fast track or automatic approval route to build capacity which is twice the country’s requirement for the next 5 years.
Many of the pharma public sector units have adequate land which could be earmarked for these 10 APIs with the help of private partnerships. End-to-end API manufacturing is a long drawn process to further encourage investments and push for economical manufacture. Government can consider a pay by use policy, where infrastructure be provided by the government at the land available in the PSU’s. This will help technocrats who find it difficult to make the heavy investments in infrastructure a base to commence production. Once they have a good market share, they can expand. This will also help academic institutes to look at technology transfers to commercial production, said Sunil Attavar, president, KDPMA.
It is high time the government gives absolute attention to APIs because it is the core of formulation development. The demand to support the API industry has been pending since long. Now it is critical if not essential as we are already very late and will need to leap frog in haste. The proposed Pharma Policy 2017 has its heart in the right place; however, there are some concerns which need to be addressed before the final is published, he added.
Another point put forth by the Association is the preference to government procurements for formulations produced from indigenously produced APIs & its intermediates which is laudable. However, KDPMA feels that verification & compliance mechanism to ensure the same will be extremely tough to implement. It may lead to controversies and potential misuse. Similar will be the case for such formulations to be kept out of price control for 5 years.
To have a level playing field, the registration and inspection of APIs should be on a reciprocal basis. The fess and inspection process much be akin to export procedures. Licenses for APIs should be on a fast track. Today it an import license takes 30 days but for an issue of domestic license, it is six months, said Attavar.
Moreover, the government should now work to tap the technical prowess of the research institutions to develop robust processes for economical manufacturing. The technology can then be transferred to PSUs or private companies at nominal fees/ royalty. This is where the KDPMA feels that that Policy should also include key intermediates and functional/speciality/combo excipients for complete supply chain solution.
In order to bolster infrastructure, state governments should be provided with incentives to set up Mega Parks . With pre-approved environment clearances, APIs should be considered as a separate exclusive category and not like hazardous chemical industries.
Treatment plants should be installed with zero discharge which is managed by the government agencies. This will ensure a balance between control and ease of business. Environment clearances must be granted on the overall pollution loads rather than on specific products. Dedicated API parks should be encouraged near non-sensitive coastal areas where the pollution norms are already notified under the Marine Environment Policy which is more liberal and successfully been implemented in areas like Tarapur in Maharashtra and Vizag in Andhra Pradesh, pointed out Attavar.
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