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The Indian Drug Manufacturers’ Association (IDMA) has asked the Union Health Ministry to implement pharmacovigilance inspection programmes in a phase manner with the first phase covering most established formulation marketers with a cut off annual turnover above Rs.500 crore, along with all manufacturers of new drugs having a significant market share.
Only when there is satisfactory evidence that each such major company marketing formulations has achieved compliance with pharmacovigilance (PV) regulatory obligations, the next lower turnover level (mutually decided upon) companies can then be enforced to follow suit after a minimum gap of three years. Such phased enforcements is essential to instill awareness and stimulate resources allocation as well as establishing necessary infrastructure by even the MSME companies in the long-run spanning over a decade, said the industry body in a representation to Drugs Controller General of India (DCGI) Dr S Eswara Reddy on draft pharmacovigilance inspection guideline.
Further, it is also necessary to create awareness amongst the medical practitioners and institutions and mandate them for reporting adverse drug reactions, the industry body said.
The draft pharmacovigilance inspection guideline was issued by CDSCO in September 2018 seeking comments from stakeholders.
The objective of the draft guideline was to facilitate compliance with various clauses of the Drugs and Cosmetics Rules, 1945 mentioned in the preamble of this guideline. However, the guideline appears to have ended up in expanding the scope of the specific clauses of the Drugs Rules and Schedule Y beyond the requirements specified since it is almost entirely based on the requirements of European Regulatory Agencies, it said.
IDMA has suggested that at present, it would be relevant to restrict only to the triggered inspections due to adverse drug events and involving high risk new drug products.
Contrary to encouraging the industry to comply with the requirements, the draft guideline discourages the industry, as the industry is under prepared in terms of resources and knowledge to comply with the requirements that are not fully understood yet. The SME marketing authorization holders may not have sufficient infrastructure to report especially other than unexpected adverse events or serious adverse events.
The industry body has sought clarification over a few grey areas. As of now it is not clarified that in case of companies manufacturing products on loan licence basis for other companies, who should report the serious adverse events and who has product liabilities. Many companies focus on selling generic drugs in bulk, and will not be able to maintain pharmacovigilance department, it stated.
Pharmacovigilance system is mandatory as a part of post marketing surveillance under Schedule Y of Drugs and Cosmetics Rules, 1945, which is primarily applicable for clinical trials of new drug products. Licensees (manufacturers of pharmaceutical products) are required to follow provisions of Schedule M. Under 28.2 of the Schedule M, licensees are required to report serious adverse drug reactions to the licensing authority.
Pharmacovigilance programme of India has been set up to assure the safety and quality of drugs by way of collection, detection, assessment, monitoring and prevention of adverse drug reactions. Pharmacovigilance guidance document for marketing authorization holders (MAHs) of pharmaceutical products has already been issued by Indian Pharmacopoeia Commission earlier in January 2018.
Besides this, Drugs and Cosmetics Rules, 1945 has been amended in October 2017 to introduce joint inspections of licensees to be conducted not less than once in three years or as needed as per risk based approach. In addition to these rules, as per Rule 52, inspectors are duty bound to inspect each licensee not less than once a year. Also additionally, the licensee has to face various inspections from various national and international regulatory agencies as well as from buyers, opined IDMA.
In view of all these, the planned, periodical, targeted and routine pharmacovigilance inspections only for the purpose of verifying compliance of pharmacovigilance system of MAH will increase the load of having to go through one more inspection team and may not be helpful to support the policy of ease of doing business. Therefore to include one more guideline for inspection at this stage may not be of much help except that a spate of special inspections can lead to lot of inconvenience to SMEs who are already under pressure of various new regulations related to labelling, BE studies etc, IDMA added.
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