Centre Moves to Redraft DCGI Appointment Rules, Tightens Eligibility Norms
The Union Health Ministry has launched a significant overhaul of the recruitment rules for the position of Drugs Controller General of India (DCGI), which is the highest authority responsible for approving and regulating medicines, vaccines, and medical devices in the country.
On November 17, the government issued a notification stating that draft rules had been prepared and circulated for feedback from stakeholders. The existing provisions regarding appointments, experience, and educational qualifications are being revised to create a more structured and technically robust selection framework.
This initiative comes at a time when the Central Drugs Standard Control Organisation (CDSCO), India’s leading drug regulatory agency, is under scrutiny. Recently, the government extended the tenure of the current DCGI, Dr. Rajeev Singh Raghuvanshi, for an additional year after his superannuation. The decision was made because there was “no suitable successor,” and leaving the post vacant was deemed detrimental to the industry.
However, this re-employment decision was challenged in the Madurai Bench of the Madras High Court, increasing the demand for a transparent recruitment process.
The draft rules significantly widen and tighten the eligibility criteria. Unlike previous regulations that primarily focused on backgrounds in pharmacy and medicine, the new proposal requires a master’s degree in engineering, biotechnology, life sciences, pharmacy, or a medical degree with a specialization in clinical pharmacology or microbiology. A PhD has also been included as a desirable qualification.
Candidates must now have a minimum of 15 years of experience in drug or device manufacturing, testing, clinical trials, regulation, or enforcement. Additionally, the maximum age for appointment through deputation has been raised from 56 to 58 years.
Other structural changes include expanding the eligible pool to officers from central and state governments, public sector undertakings, and recognized universities by including the term “administration” under the deputation eligibility criteria.
The notice invites written objections or suggestions within 30 days, after which the rules will be finalized.
The DCGI plays a crucial role in safeguarding public health by authorizing drug and vaccine approvals, monitoring safety, and ensuring compliance across the pharmaceutical and healthcare sectors. The tightening of eligibility norms is seen as a measure to ensure that the nation’s top drug regulator possesses greater technical expertise and regulatory experience.
