Apex drug regulator to more than double staff strength with 250 new positions in effort to help enforce quality norms

In addition, an additional drugs controller will be appointed for the first time at the country’s apex drug regulator and a mega-recruitment drive will start to appoint four joint drug controllers, 11 deputy drug controllers, 85 drug inspectors, especially for medical devices, and assistant drug controllers.

The recruitments will help the Drugs Controller General of India (DCGI), who heads the CDSCO, to implement good manufacturing practices for medicines and vaccines after Indian-made cough syrups were linked to the deaths of children overseas, bringing India’s pharmaceutical sector under global scrutiny. The inspectors to be recruited for India’s growing medical devices industry will have specialised skill sets.

“Around 250 posts will be added, which will double the strength at the top drug regulatory system," said one of the two people, requesting anonymity. “This will highly benefit the DCGI as the inspectors recruited, especially for medical devices, will come from mechanical or chemical engineering, polymer engineering or medical electronic engineering or engineering technology in biomedical background and will have better knowledge on advanced medical devices. There is a great demand from industry due to increased workload."

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The CDSCO has been trying to tighten quality norms after cough syrups made in the country failed tests overseas due to alleged contamination. The Indian cough syrups were linked to the deaths of children in Gambia and Uzbekistan in 2022.

“The government revises recruitment rules periodically. Till now, there was no post of additional drugs controller in the CDSCO. Currently, there is the DCGI, who is the head of the CDSCO. There are four joint drug controllers followed by deputy drug controllers and assistant drug controllers. Now, the additional drugs controller’s post will be the No. 2 position in the CDSCO," the second person said.

Improving compliance

According to the government, there are about 3,000 drug-making companies and 10,500 manufacturing units in India, with the country's pharmaceutical market projected to reach $130 billion by 2030. The country’s medical devices sector is about $11 billion and expected to grow to $50 billion by 2030.

India is the fourth-largest medical devices market in Asia after Japan, China, and South Korea and among the top 20 global medical devices markets in the world.

Also Read | Uzbek cough syrup deaths: Mandaviya asks CDSCO to probe matter, samples sent for testing

All drugs, cosmetics and medical devices in India are regulated under the Drugs & Cosmetics Act, 1940, and the Medical Devices Rules, 2017.

The CDSCO and the DCGI have been taking steps to improve compliance with quality norms with measures such as debarring applicants for misleading the licensing authority to obtain regulatory approvals, framing rules for safety and quality of imported cosmetics, and plans to amend the Medical Devices Rules, 2017, to include a provision for quality requirements for non-sterile and non-invasive devices, Mint reported earlier.

Queries emailed to the spokespersons of the health and family welfare ministry and CDSCO remained unanswered.

The doubling down on staffing at CDSCO is expected to have a global impact given that the Indian pharmaceutical industry is the world’s third largest by volume and plays a significant role internationally. 

India is one of the biggest manufacturers and exporters of vaccines globally, currently supplying several vaccines to UN agencies including UNICEF and the Pan American Health Organization. At least 60% of the World Health Organization’s vaccines for immunisation are sourced from India.

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