India's drug regulator handcuffed by low funding, lack of trained personnel

The reputation of India's massive $15 billion drug industry is being threatened at the federal and state level by a lack of properly trained personnel and a shortage of funding that points out possible changes may be needed in how the country finances inspections and quality control work, according to a report in the Business Standard.

The newspaper said almost half of all regulatory positions in the country's central and state drug offices remain unfilled and that "existing staff (are) not trained to meet the regulatory requirements of the growing sector."

These worries come despite the country setting aside $273 million to beef up the Central Drugs Standard Control Organization (CDSCO) and $132 million to beef up state regulators, the report said.

The newspaper also cited a report recently released by the Indian Council for Research on International Economic Relations that said CDSCO had a "sanctioned strength" of 111 officers in 2008 that rose to 474 by 2014.

But the actual strength of CDSCO is 220 regular officers, the Business Standard reported, compared to the U.S. Food and Drug Administration, which has 13,000 "sanctioned posts" for technical and administrative staff.

Officials cited in the report also said the government's recommendations of having one inspector for 50 manufacturing plants and retail outlets means the country should have 3,200 inspectors, but in reality the country only has 846 currently working.

Nupur Chowdhury

This means key regulatory functions such as inspections are undertaken in an ad-hoc manner Nupur Chowdhury, assistant professor, Centre for the Study of Law & Governance, Jawaharlal Nehru University, said in the Business Standard report.

"In Himachal Pradesh, inspectors have been recruited on a contractual basis. There is a risk of large-scale corruption because inspectors perform sensitive functions, including launching of prosecution," Chowdhury was quoted as saying.

"An inexperienced drug inspector has to believe in what the company says when she or he goes for inspection," said Ravi Uday Bhaskar, secretary-general, All India Drug Control Officers' Confederation, according to the Business Standard.

He also said new recruits needed at least one year of training "rather than the three-month crash courses" in use today, the paper said, and that existing staff needed a program of "continuous training" to keep up with global regulatory standards.

Chowdhury also said the country should follow the hybrid funding model that the U.S. has as opposed to its completely public financed model. The report said in fiscal 2015 the U.S. FDA was allocated $2.7 billion for safety regulation, of which the government put in $1.3 billion and user fees charged to companies brought in $1.4 billion, the Business Standard reported.

Officials also said the main problem of the lack of personnel wasn't that there were not enough trained people, but that the hiring process was staggered and took too long.

- here's the article by the Business Standard