The pharmacovigilance sector has received a much-needed booster dose with India finalizing a regulatory roadmap for post marketing surveillance of pharmaceutical products. Central Drugs Standard Control Organization (CDSCO), the office of India’s top regulator, has come out with a draft of revised guidelines for surveillance of safety of pharmaceuticals approved and sold in the market.

The regulatory agency charted out the document in association with the Indian Pharmacopoeia Commission (IPC), which currently co-ordinates various pharmacovigilance activities across the country. Practices like signal detection, safety updates or risk management etc have not been very common among the Indian firms. Select hospitals and only a small number of companies used to report adverse drug reactions (ADR), as per Phramacovigilance Programme of India (PvPI).

That is perhaps the reason why the Government of India, in a landmark decision, mandated pharmacovigilance a legal obligation for the pharmaceutical industry through a notification in March last year. It also made compulsory for firms seeking marketing approvals to have pharmcovigilance system, managed by qualified and trained personnel, in place.

The draft surveillance guidance issued by CDSCO categorizes pharmaceutical products under four broad groups: New drugs, subsequent drugs approved after 4-years; biologics; radiopharmaceuticals and phytopharmaceuticals.  
 
The focus is on identifying the risks emerging from the use of pharmaceutical products “circulating in the market after post licensure period” and setting up a pharmacovigilance system at the site of importers and manufacturers to mitigate such risks.

A site-based pharmacovigilance system should be managed with a medical officer or a pharmacist as a pharmacovigilance officer-in-charge (PVOI). This officer will collect and analyse adverse drug reaction reports related to pharmaceutical products marketed by the company in India.

The PVOI will take care of collation, processing, assessment, reporting and follow-up of individual case safety report (ICSR).

Marketing authorization holders should submit all ICSRs to National Coordination Centre, Pharmacovigilance Programme of India within the prescribed timelines, in specified electronic format as per the norms stipulated in the Schedule Y of Indian Drugs & Cosmetics Act, 1940 and Rule 1945—the pharma rule book.

In a system where PVOI is at the center, the officer also looks after detection of signal, corrective and preventive action, preparation and submission of periodic safety update report (PSUR) of new drugs and risk management system for each pharmaceutical product.

The document enlists training for system staff, framing of standard operating procedures, maintenance of quality management system of pharamacovigilance department are the responsibilities of the PVOI.

Delineating the roles and responsibilities of regulatory authorities including CDSCO, PvPI at IPC, it recommends that Pharmacovigilance System Master File (PvMF), which will contain all the information pertaining to PV system, shall be located at the site in India where the PV activities are performed.

Supervision and audits of the PV system need to be carried out by the company’s quality assurance team. Representatives from CDSCO, PvPI and concerned state licensing authority will jointly hold inspections at the place where PV activities are performed to ensure compliance with regulatory obligations.

Violators will face penal actions ranging from re-inspections to suspension of marketing authorization to delays in approvals of new marketing authorization applications until corrective and preventive actions have been implemented.

Several companies have already started establishing in-house PV systems in their organizations. While others meet the regulatory obligations through hiring services from pharmacovigilance CROs. The guidance document views contractual partners as “potential source of ICSRs” and recommends to clearly define responsibilities regarding PV activities among partners.

Meanwhile, CROs discern the regulatory move having a positive impact that will spur the growth of India’s pharmacovigilance outsourcing industry. The trend of roping in CROs for managing Indian pharmacovigilance compliance is more visible since the 2016 order mandating PV cells.

However, Indian companies with a generic mindset could take some time to understand that global pharmacovigilance obligations are no different for innovators and generic drug makers and to accept pharmacovigilance as an integral part of their system, according to Dr. Venkatraman.

Evidently, implementation of good pharmacovigilance practices is expected to improve compliance and reduce the current gap in post marketing surveillance and drug safety that exist between India and other tightly regulated markets.