FOPE seeks CDSCO clarification on pharmacovigilance obligations under revised Schedule M

The Federation of Pharma Entrepreneurs (FOPE) has sought clarifications from the Central Drugs Standard Control Organization (CDSCO) on the implementation of pharmacovigilance (PV) requirements under the revised Schedule M, citing ambiguities that could lead to inconsistent interpretation and compliance across the pharmaceutical industry.

In a representation addressed to the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, FOPE requested detailed guidance on the implementation of Paragraph 6.11 of the revised Schedule M following a CDSCO circular issued on June 3, 2026, directing stakeholders to establish and maintain an effective pharmacovigilance system in accordance with the Drugs and Cosmetics Act, 1940, the revised Schedule M and the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The industry body, which represents pharmaceutical manufacturers with a strong focus on MSMEs, said regulatory clarity is essential to ensure uniform implementation by manufacturers, marketers and licensing authorities.

One of the key issues highlighted by FOPE relates to pharmacovigilance responsibilities in third-party or contract manufacturing arrangements. Under Paragraph 6.11 of the revised Schedule M, licence holders are required to maintain a pharmacovigilance system for collecting, processing and forwarding reports of adverse drug reactions arising from drugs “manufactured or marketed by the licensee.”

FOPE has requested CDSCO to clarify whether this responsibility should rest with the manufacturing licence holder or the marketing company whose name appears on the product label. The association argued that where products are manufactured under contract and marketed by another company, the marketer should be considered responsible for pharmacovigilance obligations, as marketers are already responsible for product quality under the Drugs Rules, 1945.

The representation also seeks clarification on the distinction between the general pharmacovigilance requirements prescribed under Schedule M and the Periodic Safety Update Report (PSUR) requirements under the NDCT Rules, 2019. FOPE noted that while Schedule M appears to mandate a pharmacovigilance system for all marketed products, PSUR submissions under the NDCT Rules are specifically linked to new drugs.

The association has therefore requested CDSCO to clarify whether Schedule M requires only a general pharmacovigilance system for marketed products, while PSUR submissions remain applicable exclusively to new drugs as defined under the NDCT Rules.

A third issue raised by FOPE concerns the applicability of the NDCT Rules, 2019 to products approved before the Rules came into force. The association has sought clarification on whether PSUR obligations apply only to new drugs approved after 2019 or whether they are intended to cover products that received regulatory approval prior to the commencement of the NDCT Rules.

FOPE said such clarifications would help manufacturers, marketers, State Licensing Authorities and CDSCO’s zonal offices adopt a consistent approach towards pharmacovigilance compliance. The association has urged the regulator to issue suitable guidance to facilitate uniform implementation of the revised Schedule M provisions across the pharmaceutical sector.