The Centre has approved a one-year extension for Rajeev Singh Raghuvanshi as India’s top drug regulator, effective March 1, allowing him to continue as the Drugs Controller General of India (DCGI) on a contractual basis. The move comes as the government has kept regular recruitment rules for the position in abeyance, signalling a push for leadership continuity at the Central Drugs Standard Control Organization (CDSCO) during a phase of regulatory reforms.
Raghuvanshi took charge in February 2023 after serving as Secretary-cum-Scientific Director at the Indian Pharmacopoeia Commission. With prior leadership roles at Dr. Reddy’s Laboratories and Ranbaxy, his appointment marked a departure from tradition, bringing private-sector technical experience to a role typically held by career bureaucrats. He succeeded V.G. Somani at a time when Indian pharmaceutical exports were facing heightened global scrutiny.
During his tenure, he has led an assertive quality-control drive. Following global reports of contaminated cough syrups, CDSCO conducted inspections of around 1,100 manufacturing units and issued over 850 corrective action notices. Revised Schedule M norms were rolled out, mandating higher Good Manufacturing Practices (GMP) standards aligned more closely with those followed by the USFDA. The regulator also launched a digital dashboard to track drugs failing “Not of Standard Quality” (NSQ) tests, aimed at enhancing transparency and accountability.
However, his reappointment has drawn criticism. The government’s decision to retain him outside the standard recruitment framework has been challenged before the Madurai bench of the Madras High Court, with questions raised over the transparency of the selection process.
While large pharmaceutical companies have largely supported his quality-first approach, small and medium-sized manufacturers argue that the rapid enforcement of stricter standards has disproportionately affected smaller units. His tenure has also seen debate within the industry over approval timelines and the clarity of data regarding spurious and sub-standard drugs in the domestic market.
