India’s apex drug regulatory authority remains understaffed with less than half its sanctioned drug inspectors currently in place more than a decade after a parliamentary panel had flagged similar shortages and recommended corrective action.
The Union chemicals and fertilisers ministry told Parliament on Friday that the Central Drugs Standard Control Organisation (CDSCO) was, as on December 4, 2023, functioning with 201 drug inspectors, less than half of the 504 sanctioned posts.
The ministry’s department of pharmaceuticals, in a written response to a question by MP Sridhar Kotagiri, said the CDSCO had 303 vacancies. The ministry also told Kotagiri — who had asked for state-wise counts of sanctioned and vacant posts — that the Centre does not maintain information on posts for which state governments are responsible.
A CDSCO official told The Telegraph on Saturday: “The recruitment process is on.”
The shortages imply that the CDSCO — an agency tasked with overseeing the activities of India’s 3,000 pharmaceutical companies and 10,500 manufacturing units — has not addressed shortages underlined by a parliamentary standing committee on health in 2012.
The parliamentary panel, noting that only 124 of the 327 sanctioned posts at the time were occupied, had expressed concern that such staff shortages would limit the ability of the CDSCO to discharge its functions efficiently.
India’s drug regulatory apparatus is divided between the Centre and states — each state has its own drug regulatory agency. However, the CDSCO is the sole authority responsible for the approval of all drug formulations manufactured and sold in the country. CDSCO drug inspectors are also tasked with picking up random samples of medicines for quality tests and, since 2018, have been conducting joint inspections of drug manufacturing units with the state regulators.
Analysts tracking India’s pharmaceutical industry and the CDSCO have long speculated that staff shortages and lack of skills at the central and state level contribute to constraining the regulatory authorities’ capacity to effectively ensure that all drug manufacturing units rigorously adhere to mandatory “good manufacturing practices”.
Over the past year, regulatory authorities in other countries have sounded alerts about cough syrups contaminated with toxic chemicals and eye drops associated with infections that had been produced and exported by Indian companies.
India exports pharmaceuticals to more than 200 countries.
Prashant Reddy, a lawyer who specialises in intellectual property, has studied India’s drug regulatory apparatus and co-authored a book on drug regulation, said the CDSCO and state regulators would need to do much more than merely fill vacant posts.
“Most drug inspectors are qualified pharmacists — but inspections and regulatory enforcement demands expertise across multiple disciplines such as manufacturing and microbiology — even legal knowledge is required for regulatory enforcement,” Reddy said.
A 2015 report by consultants with the Indian Council for Research on International Economic Relations had also noted what they had described as the “lack of interest, commitment, and financial investment” in creating permanent positions, specifically drug inspectors.