NEW DELHI: The government plans to more than double the staff strength of the Central Drugs Standard Control Organization (CDSCO) and fill 250 new posts to strengthen enforcement of good manufacturing practices for drugs, vaccines and medical devices, two people familiar with the matter said.
In addition, the country’s top drug regulatory agency will appoint a drug regulator for the first time and will start a large-scale recruitment drive to appoint 4 joint drug regulators, 11 deputy drug regulators, 85 drug inspectors (especially medical device inspection Officer) and Assistant Drug Controller.
The recruitment will help the Drug Controller General of India (DCGI) head CDSCO, which will help it enforce good manufacturing practices for drugs and vaccines, after Indian-made cough syrup was linked to child deaths overseas, putting the Indian pharmaceutical industry under global scrutiny. The inspectors recruited for India’s growing medical device industry will have specialized skills.
“Around 250 posts will be created, which will double the strength of the apex drug regulatory system,” two people said on condition of anonymity. “This will greatly benefit the DCGI as the number of inspectors recruited, especially medical Device inspectors, who will come from mechanical or chemical engineering, polymer engineering or medical electronic engineering or engineering backgrounds in biomedicine and have a better understanding of advanced medical devices, are in high demand in the industry due to the increase in workload.
CDSCO has been working to tighten quality standards after cough syrup produced in the country failed overseas tests due to alleged contamination. Indian cough syrup linked to child deaths in Gambia and Uzbekistan in 2022.
“The government regularly changes recruitment rules. So far, there has been no additional drug controller post in CDSCO. Currently there is DCGI, who is the head of CDSCO. There are four joint drug controllers, followed by deputy drug controller and assistant drug controller . Now, the additional drug controller post will be the number two post in the CDSCO,” said a second person.
Improve compliance
According to the government, there are about 3,000 pharmaceutical companies and 10,500 manufacturing units in India, and the country’s pharmaceutical market is expected to reach $130 billion by 2030. to $50 billion.
India is the fourth largest medical device market in Asia after Japan, China, and South Korea, and is also one of the top 20 largest medical device markets in the world.
All drugs, cosmetics and medical devices in India are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.
CDSCO and DCGI have been taking steps to improve compliance with quality norms, including prohibiting applicants from misleading licensing authorities in obtaining regulatory approvals, formulating safety and quality rules for imported cosmetics, and planning to amend the Medical Devices Rules, 2017, to include non-native stipulations on quality requirements for bacteria and non-invasive equipment, Mint reported earlier.
Queries emailed to spokespersons of the Ministry of Health and Family Welfare and CDSCO remained unanswered.
This will greatly benefit DCGI as the inspectors recruited will have a better understanding of advanced medical equipment.
Given that the Indian pharmaceutical industry is the third largest in the world by volume and plays an important role internationally, the increase in CDSCO staffing is expected to have a global impact.
India is one of the world’s largest vaccine manufacturers and exporters and currently supplies several vaccines to United Nations agencies including UNICEF and the Pan American Health Organization. At least 60% of the World Health Organization’s immunization vaccines come from India.
