Nationwide inspection of drug cos, importers planned to assess pharmacovigilance practices

Nationwide inspection o

In a bid to prevent adverse events associated with medicinal products, the Central Drugs Standard Control Organisation (CDSCO) is getting ready to conduct nationwide inspection of pharmaceutical manufacturers and importers to assess their pharmacovigilance (PV) practices. The national drug regulator, after a meeting last week with industry associations and representatives of pharmaceutical majors, has issued a guidance document for the National PV-inspection Programme (NPVIP). The norms are applicable to producers and importers of pharmaceuticals, phyto-pharamaceuticals, human vaccine, blood products, rDNA technology-derived drugs and stem cell therapeutics.

The PV inspections would be prioritised on the basis of potential risk to public health and the results from across the country will be sent to the Drugs Controller General of India (DCGI) for further reviewing by a panel constituted at the CDSCO headquarters. Based on the dynamic list of new drugs approved by the DCGI from time to time, the PV section at the CDSCO will prepare a four-year programme for routine inspections which would be revised on year-to-year basis. As per the norms, companies that are placing more new drugs in the market will be prioritised for systemic PV inspection, depending on categories and frequencies of market launch. Re-inspection frequency will depend on changes to the system since the previous inspection or on critical findings identified during reviews. The regulator will prioritise a company if it comes to know about frequent post-approval changes on marketed medicinal products or gets Adverse Drug Reaction (ADR) alerts from government bodies or procurement agencies.

Involvement in a merger/takeover process or a large product range with high sales volume could also put a firm under watch. The move to scrutinise the PV practices of companies comes nearly two years after the government’s decision to amend Schedule Y of the Drugs and Cosmetics Act of 1940 to make the mechanism mandatory. As per the amendment, any firm applying for a new drug licence should have a PV system in place for collecting, processing and forwarding the report to the licensing authority for information on ADR. Subsequent to approval, the product should be closely monitored for clinical safety once it is marketed and the firm needs to submit periodic safety update report every six months for first 2 years and every year for the next two years. In the last few years, India has adopted several measures to tighten the PV programme. A National Coordination Centre, constituted to keep ADR incidents in check, is functioning in collaboration with the global ADR monitoring base in Sweden. The Indian centre contributes regularly to the global ADR database and helps regulators take decisions on safe use of medicines. As many as 250 health facilities across the country have already enrolled as monitoring centres.

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