To ensure regulatory compliance by pharma companies, the central drug regulator has decided to engage third-party certification bodies approved by the Quality Council of India (QCI). A senior official told FE that the move to strengthen the auditing capacity of the Central Drugs Standard Control Organisation (CDSCO) has come to make the regulatory system more robust, to address the shortage of manpower and plug the structural gaps in compliance monitoring.
“With the expanding size of the pharma sector coupled with the need to ensure strict compliance with the WHO’s good manufacturing practices (GMP), a proposal to engage third-party competent bodies is being finalised,” the official said.
Revised Schedule M (GMP) guidelines to come into effect from Jan 1
Beginning January 1, the revised Schedule M (GMP) guidelines have come into force for the small and medium-sized pharma companies under which they will be subjected to infrastructure upgrades, documented quality risk management, and routine inspections related to product safety.
Currently, the inspection of pharma units are conducted by CDSCO’s drug inspectors and state regulatory authorities. It’s estimated that nearly 50% of the sanctioned strengthen of drug inspectors are vacant at the CDSCO.
“The absence of adequate drug inspectors not only weakens the monitoring and regulation of the pharma industry but also enhances the risk of spurious medicines entering the market,” the official said.
With the recent incidents of cough syrup batches containing toxic ingredients, the CDSCO has drawn plans to tighten the factory checks and enhance post-marketing surveillance.
These certification bodies will be part of the QCI’s National Accreditation Board for Certification Bodies (NABCB) which is already recognised by various regulators such as FSSAI, PNGRB, and DGCA for accrediting.
Medical device audits
To be sure, medical device audits are already being conducted by third-party certification bodies under the Medical Devices Rules 2017. These bodies conduct audit quality management systems for Class A & B devices and assist in technical reviews for Class C & D.
“For the true success of this step, the notified bodies’ work must be sample-supervised by regulators and NABCB, with regular feedback from stakeholders,” said Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AiMeD).
In the Budget 2026-27, the finance minister Nirmala Sitharaman had proposed to “strengthen the CDSCO to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists.”
Earlier, the central drugs regulator said that it’s planning to create 1,500-member scientific cadre to accelerate the drug approvals and align with international agencies like the USFDA.