Pharma industry confounded by lack of clarity in draft notification on post marketing drug safety surveillance is waiting for the Central Drugs Standard Control Organisation (CDSCO)'s revised guidelines which will resolve their ambiguity in implementation of pharmacovigilance programme.
The draft notification on post marketing surveillance of pharmaceutical products in India was issued by Union health ministry on March 8, 2016 seeking comments from the pharma industry before finalising it.
The notification lacked clarity to make it implementable by the pharma industry.
Hence a 15-member committee representing 60 pharmaceutical companies was set up with Dr Jamal Anwar Baig, country head, pharmacovigilance, Merck Sharp & Dohme as point of contact to suggest measures to be adopted to ensure smooth implementation of regulation of post marketing surveillance of pharmaceutical products.
The Committee submitted its suggestions to Indian Pharmacopoeia Commission (IPC), national coordinating authority (NCC) of Pharmacovigilance Programme of India (PvPI) in November 2016. The committee's suggestions were forwarded to CDSCO by IPC to look into it.
The panel in its report recommended for setting of pharmacovigilance system at each pharma manufacturing unit which will collect, process and forward report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the company in the country.
It further suggested appointing trained medical officer, pharmacist to handle pharmacovigilance system who will be responsible for collection and analysis of ADR report. It also suggested training module to educate field force i.e. medical representatives to report ADRs.
Besides this, the committee suggested making it compulsory for pharma industry to conduct third party audit of pharmacovigilance system. It also proposed that it should be made compulsory for marketing authorisation holders and license holders manufacturing products in India to submit risk management plan to ensure drug safety at par with EU, USA.
“Our recommendations are aligned with draft regulation of post marketing pharmacovigilance issued in March 2016”, said Dr Baig.
Till March 2016 we did not have any regulation making it compulsory for pharma company to put in place pharmacovigilance system. Taking advantage of it, most of the drug makers have not set up pharmacovigilance unit. Once CDSCO comes out with new guidelines, pharma companies will be forced to put in place pharmacovilance system thereby increasing ADR reporting in the country, he concluded.