With effect from March 1, the Center has granted Rajeev Singh Raghuvanshi a one-year extension to serve as India’s top drug regulator.
A government order outlining the ruling permits Raghuvanshi to serve as the Drugs Controller General of India (DCGI) on a contractual basis.
The action indicates a preference for leadership continuity within the Central Drugs Standard Control Organization (CDSCO) amid ongoing regulatory reforms, as the government suspends regular recruitment criteria for the position.
In February 2023, Raghuvanshi took over from his position as the Indian Pharmacopoeia Commission’s Secretary-cum-Scientific Director.
His appointment was initially perceived as an attempt to introduce technical competence from the corporate sector to a position often occupied by internal promotees or career bureaucrats. He is a pharmaceutical industry veteran with prior leadership positions at Ranbaxy and Dr. Reddy’s Laboratories. In the midst of increased worldwide scrutiny of Indian-made pharmaceuticals, he assumed the role after V.G. Somani’s term.
An aggressive “clean-up” of the local manufacturing scene has been a defining feature of his performance. Raghuvanshi coordinated a statewide operation that included inspecting around 1,100 manufacturing facilities and issuing over 850 corrective action letters in response to accusations of tainted cough syrups from throughout the world.
The updated Schedule M standards, which forced Indian firms to adhere to Good Manufacturing Practices (GMP) more closely to those prescribed by the USFDA, were pushed through by his administration. In an effort to hold manufacturers responsible, the CDSCO also introduced a digital dashboard to track medications that fail “Not of Standard Quality” (NSQ) testing.
Raghuvanshi’s leadership has encountered ongoing criticism and legal obstacles in spite of these efforts. Critics have questioned the appointment process’s transparency, challenging the government’s choice to retain him by circumventing the usual recruitment process in the Madurai bench of the Madras High Court.
Large pharmaceutical companies have generally backed his quality-first strategy, while small and medium-sized businesses (SMEs) contend that the quick adoption of strict regulations has caused a disproportionate number of smaller businesses to close.
His tenure has also been characterized by public debate over the clarity of data released regarding the prevalence of sub-standard versus spurious drugs in the Indian market, as well as accusations from some industry quarters regarding “perception management” and the speed of specific drug approvals.
