 "Personnel shortage, lack of funding hold back India's drug regulator")
The Centre recently approved Rs 1,750 crore to strengthen the drug regulatory system in the country. This Rs 900 crore would be for strengthening the Central Drugs Standard Control Organisation (CDSCO) and Rs 850 crore for state drug authorities.
The staff strength in CDSCO, whose responsibilities include new approvals and blood banks, and in state drug regulatory authorities that have the onus of renewal of licences, are not adequate, say experts.
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A report titled 'Administrative structure and functions of drug regulatory authorities in India,' by the Indian Council for Research on International Economic Relations (Icrier), released in September, states CDSCO had a sanctioned strength of 111 posts in 2008, increased to 474 by 2014.
"The actual strength is 220 regular officers. The remaining 254 posts have been advertised through Union Public Service Commission (UPSC). UPSC's recruitment process is often staggered and delayed. To cope with this, 250 contractual staff have been recruited to assist in processing applications for new drugs and clinical trials," said the report.
Another report by the task force on 'enabling the private sector to lead growth of the pharmaceutical sector', under the chairmanship of the department's secretary, also cites the shortage of personnel at CDSCO.
It highlights the staff strength of the US Food and Drug Administration (FDA), which has 13,000 sanctioned posts of technical and administrative staff.
Messages and calls to CDSCO did not elicit response. However, sources from the regulatory authority said the efforts were on to improve the working in two or three years. CDSCO has already recruited the first batch of 29 assistant drug inspectors after the sanctioning of Rs 1,750 crore, and the batch is undergoing a three-month training, sources added.
The situation at state drug control organisations is similar. The task force cited above has recommended one drug inspector for 50 manufacturing units, as well as one inspector for every 200 sales and distribution outlets for effective implementation of the assigned functions to state drug regulatory authorities.
"There are approximately 600,000 retail sales outlets and 10,500 manufacturing units in the country, which require 3,200 drugs inspectors. There were only 846 drug inspectors, against 1,349 sanctioned posts in the states," noted the task force.
The All India Chemists and Druggists Association claims there are around 800,000 retail outlets. By this, the requirement would be around 4,000 drug inspectors, says an official.
This has led to a situation where key regulatory functions such as inspections are undertaken in an ad-hoc manner due to non-recruitment of permanent employees, says Nupur Chowdhury, assistant professor, Centre for the Study of Law & Governance, Jawaharlal Nehru University.
"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," said Chowdhury, also a lead researcher for Icrier's research project on drug regulatory reforms in India.
"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 (AIDCOC).
He said those who inducted afresh should have a training programme for at least a year, rather than the three-month crash courses at present. Also, the existing staff should be put on continuous training to keep up with global regulatory standards and requirements of the sector.
While the government is expected to come up with skills development for the drug regulators soon, AIDCOC is looking to set up a training institution for existing control officials and students.
Funding mechanism
"In India, we follow a public finance model, against a partial user fee model in the US. We have suggested a hybrid model, based on partial user fees, reflecting the cost of services and a public finance model should be explored in the context of India," said Chowdhury. According to Icrier, in FY15 in the US, $2.7 billion was allocated to programme-level funds of medical products' safety regulation, of which the government-funded $1.3 billion and user fees provided $1.4 billion.
Financial autonomy in revenue generation and disbursement will address delays from complicated and lengthy systems for disbursement. Financial models partly funded by budgetary allocations and partly by user fees should be explored, says Icrier.
According to Chowdhury, it would be a simplification to suggest the problems of drug regulation are only a function of lack of funding. The 82nd report of Parliament's standing committee on the functioning of ministry of health and family welfare, under-utilisation of funds is a recurring problem, which is partly due to the complicated system of approvals for disbursement of funds. Giving financial autonomy to the CDSCO could address this.
Uday Bhaskar says the fees are negligible and not at all considered as a means to improve the facilities of the drug control offices. For instance, an additional drug licence has a fee of Rs 300, which has been the same for several years now. States charge Rs 500 if they take part in a joint inspection, while CDSCO does not charge. These funds are not directly utilised to improve the facilities of the drug control office and funding has to come from parent departments through budgetary allocation.
According to industry sources, there is no dearth of skilled personnel available for recruitment. There are hundreds of colleges across states teaching B Pharm, the basic qualification to be a regulatory official.
Experts also blame the staggered and protracted nature of recruitment through public service commissions for the lack of staff. This is again related to the need for having an autonomous CDSCO.