Rajeev Raghuvanshi gets one year extension as India’s top drug regulator

DCGI

• Rajeev Singh Raghuvanshi gets one-year extension as DCGI chief
• He led GMP reforms and crackdown on substandard drug units
• His reappointment faces legal challenges over recruitment process

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The Centre has approved a one-year extension for Rajeev Singh Raghuvanshi as India’s top drug regulator, effective March 1. The decision, detailed in a government order, allows Raghuvanshi to continue as the Drugs Controller General of India (DCGI) on a contract basis.

The move comes as the government keeps regular recruitment rules for the post in abeyance, signaling a preference for leadership continuity within the Central Drugs Standard Control Organization (CDSCO) amid ongoing regulatory reforms.

Raghuvanshi’s tenure began in February 2023, when he transitioned from his role as Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission.

A veteran of the pharmaceutical industry with previous leadership roles at Dr. Reddy’s Laboratories and Ranbaxy, his appointment was initially seen as an effort to bring private-sector technical expertise to a role traditionally held by career bureaucrats or internal promotees. He took over the position following the term of V.G. Somani during a period of heightened international scrutiny of Indian-made pharmaceuticals.

His performance has been characterized by an aggressive "clean-up" of the domestic manufacturing landscape. Following global reports of contaminated cough syrups, Raghuvanshi oversaw a nationwide crackdown that included the inspection of approximately 1,100 manufacturing units and the issuance of over 850 corrective action notices. His administration pushed through the revised Schedule M norms, which mandated that Indian factories meet Good Manufacturing Practices (GMP) closer to those required by the USFDA. To increase transparency, the CDSCO also launched a digital dashboard to track drugs that fail "Not of Standard Quality" (NSQ) tests, a move intended to hold manufacturers accountable.

Despite these initiatives, Raghuvanshi’s leadership has faced persistent criticism and legal hurdles. The government’s decision to bypass standard recruitment procedures to retain him has been challenged in the Madurai bench of the Madras High Court, with critics questioning the transparency of the appointment process.

While large-scale pharmaceutical firms have largely supported his quality-first approach, small and medium-sized enterprises (SMEs) have argued that the rapid implementation of stringent standards has led to the disproportionate closure of smaller units.

Additionally, his tenure has been marked by allegations from some industry quarters regarding "perception management" and the speed of specific drug approvals, as well as public debate over the clarity of data released regarding the prevalence of spurious versus sub-standard drugs in the Indian market.