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 The Federation of Pharmaceutical Entrepreneurs (FOPE) has made a representation to the Central Drugs Standard Control Organization (CDSCO) and the Directorate General of Health Services (DGHS) seeking clarification regarding implementation of Pharmacovigilance System as per Para 6.11 of Revised Schedule M and NDCT Rules, 2019.
We need information on certain practical and regulatory aspects from the referred circular, wherein all stakeholders have been directed to ensure establishment and maintenance of an effective pharmacovigilance system in compliance with the Drugs and Cosmetics Act, 1940, the Rules, and the New Drugs and Clinical Trials Rules, 2019, said Harish K Jain, president, FOPE.
Clarification is needed on the term ‘marketed by the licensee’ in case of third-party/contract manufacturing arrangements in Para 6.11 of Revised Schedule M. It provides that the licensee shall have a pharmacovigilance system in place for collecting, processing and forwarding the reports to the licensing authorities on the adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee.
In the pharmaceutical industry, many products are manufactured by one company as contract manufacturers, while the product is marketed, sold, distributed, promoted and commercially handled by another company as marketing company.
In such cases, clarification is requested as to whether the pharmacovigilance obligation for collecting, processing and forwarding adverse drug reaction reports would lie with the manufacturing licence holder/contract manufacturer and the marketer whose name appears on the product label.
It is submitted that where the drug is marketed by a company other than the manufacturer, the marketer, defined under Rule 2(ea) of the Drugs Rules, 1945, will be responsible for pharmacovigilance, since the marketer is responsible for the drug quality under Rule 84D. Therefore, a specific clarification is required on the responsibility of marketers in relation to PV reporting obligations, particularly for products manufactured through third-party/contract manufacturing arrangements, said Jain.
Also, Para 6.11 of Revised Schedule M o requires pharmacovigilance for drugs manufactured or marketed by the licensee. This requirement appears to be a general pharmacovigilance obligation applicable to licensed manufacturers/marketers for marketed products. However, under the New Drugs and Clinical Trials Rules, 2019, the requirement of “Post Marketing Surveillance through Periodic Safety Update Reports” is specifically provided under the provisions relating to new drugs.
Now the industry needs to know Para 6.11 of Revised Schedule M requires maintenance of a general pharmacovigilance system for already approved/marketed drugs when PSUR (Periodic Safety Update Report) submission under the NDCT Rules, 2019 are applicable only to new drugs. We need a clear distinction between general pharmacovigilance system requirements under Schedule M and PSUR submission obligations under NDCT Rules, 2019 which would help stakeholders ensure correct and uniform compliance, said Jain.
The NDCT Rules, 2019 were enforced in 2019 and are applicable to new drugs and clinical trials. As a settled principle, unless expressly provided, a law is generally prospective in operation and does not ordinarily have retrospective effect. Accordingly, clarification is requested on whether PSUR obligations under the NDCT Rules, 2019 are applicable only to new drugs approved after commencement of the NDCT Rules, 2019, or whether such obligations are also intended to apply retrospectively to drugs approved prior to 2019, he said.
This clarification is important for manufacturers and marketers handling products that were already approved and marketed prior to the commencement of the NDCT Rules, 2019, said Jain.
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