There is a realization in the Indian pharma industry to become self-reliant in the development of Active Pharmaceutical Ingredients (APIs) however it will take some effort to accomplish the objective, a top Indian Pharmaceutical Alliance (IPA) official said on Wednesday.
The IPA is an alliance of 24 top research-based pharmaceutical firms including Dr. Reddy’s, Lupin, Sun Pharma, and Cipla.
“Reliance on China API’s is still there… We had the technology of making all kinds of API 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,” Sudarshan Jain (IPA) Secretary-General said
Jain however noted that it will take some time for the country to get self reliance in API production.
Jain also said that the IPA has been in constant touch with the US Food and Drug Administration (USFDA) regarding the start of inspections.
“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.
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 organizations have sought 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 stabilized 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 up-gradation of the B Pharm and M Pharm courses to meet the latest industry expectations.
The organization is also working to train the faculty of pharmacy colleges on the latest technological advancements to enhance faculty’s practical experience.
The association is likewise attempting to prepare the personnel of drug store schools on the furthest down the line mechanical headways to upgrade the workforce’s pragmatic experience.
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