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It's time industry and govt team-up to list down top 10 most critical APIs to focus on time-bound production: KPDMA
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Nandita Vijay, Bengaluru
August 31 , 2017
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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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