Realisation there in pharma industry to become self reliant in API production: IPA

There is a realisation in the domestic pharma industry to become self reliant in the production of active pharmaceutical ingredients (APIs) but it will take some time to achieve the goal, a top Indian Pharmaceutical Alliance (IPA) official said on Wednesday.

IPA, which represents 24 leading research-based drug firms including

, Dr Reddy’s, Cipla and , noted that Indian industry had the know-how to produce APIs but somehow lost the advantage to countries like China.

“Reliance on China for APIs is there…We had the technology of making all kinds of APIs but over a period of time we lost that advantage. But now with production linked incentive (PLI) scheme which covers APIs and coming up of manufacturing parks we are on the right path,” (IPA) Secretary General Sudarshan Jain said during an event.

There is a realisation and some of the companies are taking a big lead and this is clearly one of the agenda where the industry is working together, he added.

Jain however noted that it will take some time for the country to get self reliance in API production.

“The overall fundamental point in all this is that there has to be a diversified supply chain. Every manufacturer cannot be dependent on a single supply source. Unfortunately for a long time we have relied too much on one source. We don’t have answers at the moment and we continue to source from outside till we create our own capability in the future,” he said.

Jain also said that the IPA has been in constant touch with the US Food and Drug Administration (USFDA) regarding the start of inspections.

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The US health regulator since last year has halted nearly all inspections of overseas drug manufacturing plants citing the spread of the coronavirus pandemic, affecting new drug approvals.

“As far as USFDA inspections are concerned we are having constant meetings. We have been talking to them and checking for the possibility of combining virtual and physical inspection together. The dialogue is on but there are no answers till now as far as this area is concerned,” Jain said.

Various organisations have sought for virtual inspection, but it has not been accepted by the USFDA till now, he added.

IPA continues to have dialogue because it is important to make sure that products are available and there are choices in terms of drugs with the citizens across the world, Jain said.

He also stated that the production levels have now stabilised across the pharma sector after witnessing a drop last year due to the COVID-19 pandemic.

Jain noted that IPA is closely working with the Pharmacy Council of India for course curriculum and syllabus upgradation of the B Pharm and M Pharm courses to meet latest industry expectations.

The organisation is also working to train the faculty of pharmacy colleges on the latest technological advancements to enhance faculty’s practical experience.


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