Govt adds 49 drug inspectors. 181 posts still remain vacant.
- Despite new hires, more than a third of sanctioned drug inspector posts remain unfilled, raising concerns over oversight of India’s vast pharmaceutical sector.
Six months after a government report showed an alarming shortage of drug inspectors in the country, the Union health ministry has appointed 49 candidates to the role.
Out of 419 sanctioned posts for drug inspectors under the Central Drugs Standard Control Organisation, only 189 were filled as of February, according to a seniority list published by CDSCO in February. Even with the 49 new inspectors, 181 posts remain unfilled.
CDSCO’s medical devices unit has another 85 sanctioned posts for drug inspectors, but 80% of those were vacant as of November.
Drug inspectors are authorized to inspect drug manufacturing units and sales outlets, take samples for analysis, and ensure compliance with quality and safety standards under the Drugs and Cosmetics Act, 1940.
Their role is essential to regulating India’s vast and complex pharmaceutical industry that has more than 3,000 drug manufacturing companies.
According to a reply in Parliament in 2023, the exact requirement for drug inspectors nationwide was unclear. But a decade earlier, in 2003, a committee led by Dr. R.A. Mashelkar recommended a ratio of one drug inspector for every 50 manufacturing units and one for every 200 sales units.
The chronic shortage of drug inspectors has been a persistent issue, which pharma industry experts attributed to delays in the recruitment process.
In December, a Parliamentary standing committee on chemicals and fertilisers noted that 60% of the sanctioned drug inspector posts at the CDSCO were vacant as of December 2023.
Even the 504 sanctioned posts for drug inspectors is not enough for a country with more than 750 districts, it added, urging the government to prioritize filling the vacancies without delay.
A global powerhouse
A government official said the Union ministry of health and family welfare is working to address the gap in appointing drug inspectors.
“The government is now recruiting more drug inspectors and filling this gap recognizing their vital role in ensuring a robust and effective drug regulatory system," the official said on condition of anonymity.
“The shortage of personnel exists because already sanctioned positions remain unfilled," said another official familiar with the matter. “Ideally, drug inspectors should be recruited as vacancies occur. However, as a matter of procedure, the department consolidates a list of vacancies over several years before filling the posts, which creates a significant gap."
The 49 new appointments were formalized in a gazette notification dated 19 September.
“A strong drug regulatory system requires robust infrastructure and talent. The government’s recruitment of 49 new drug inspectors is a step in this direction," said Sudarshan Jain, secretary, Indian Pharmaceutical Alliance, an organization representing 23 major pharmaceutical companies.
Despite the regulatory challenges and staff shortage, India’s pharmaceutical sector remains a powerhouse on the global stage. According to the Department of Pharmaceuticals, India’s pharma exports increased to $30.47 billion in 2024-25 from $26.5 billion in FY24.
Dr. Sharan Shivaraj Patil, chairman of SPARSH Group of Hospitals, called for robust vigilance and zero tolerance for spurious drugs.
“Counterfeit or ineffective drugs are as dangerous as a disease itself because they fail to deliver their intended purpose. India’s global reputation as a major drug manufacturer relies on strict adherence to regulations. Any shortcuts put lives at risk," he said.
Queries sent to the health ministry spokesperson on Monday remained unanswered.
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