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Shortage of drug inspectors poses a regulatory challenge

Shortage of drug inspectors poses a regulatory challenge
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First Published: Thu, Mar 29 2007. 03 13 AM IST
Updated: Thu, Mar 29 2007. 03 13 AM IST
Hyderabad: India faces a severe shortage of drugs inspectors, who ensure that medicines made and sold in the country are safe for consumption.
There are about 1,300 drugs inspectors in India, less than a fourth of the number required, says the All India Drugs Control Officers’ Confederation (AIDCOC), a representative group of drugs officers.
The country needs more than 5,500 drugs inspectors, who are responsible for conducting inspections of pharmaceutical companies for issuing and renewing manufacturing licences, based on staffing standards recommended by the Union government. The inspectors also license pharmacy stores.
Drugs officers and inspectors form an important cog of the quality control process in the pharmaceuticals industry. States risk non-compliance of good manufacturing practices, a mandatory certification for pharmaceutical manufacturing units, with inadequate drugs control manpower.
“The existing manpower in this critical health department cannot effectively monitor or regulate the 15,000-odd pharmaceutical companies and 500,000 pharmacy stores across the country,” said Ravi Uday Bhaskar, secretary general, AIDCOC.
A Union government taskforce in 1982 had recommended that one drugs inspector for every 25 manufacturing units and one for every 100 pharmacies be appointed.
For instance, Andhra Pradesh, one of the key states in the pharmaceutical map of India, known for its bulk drugs and vaccines production, has an estimated 40,000 pharmacy stores, 236 blood banks and 1,200 manufacturing units. And to police all this, the state drugs department has just 84 drugs officers, 16 of them on short-term contracts.
The situation is not better in other parts of the country either. Gujarat, Goa and Himachal Pradesh, all with significant numbers of drug makers and pharmacy stores, face a similar shortage.
Himachal Pradesh, which recently emerged as a hub for formulations, with the state’s industrial centre Baddi attracting pharmaceutical investments, has 200 units today, but just six drugs inspectors. Goa has four drugs officers.
“The problem will be solved only when states realize that the drugs department is a key component of the health-care system,” Bhaskar added.
Ten drugs inspectors look after the nearly 1,500 retail pharmacies, six blood banks and two small-scale manufacturing units in Tripura.
“Even if the department seeks to strengthen its team, quality candidates are not available. The situation is the same in most of the North-eastern states,” said Mihir Kumar Pal, deputy drugs controller and licencing authority, Tripura.
Some states, on the other hand, have ensured adequate manpower. Maharashtra has about 150 drugs inspectors. The state department has also created an exclusive intelligence wing, backed by the police department, to conduct raids on spurious and substandard drugs manufacturing units and check otherviolations.
West Bengal has some 90 inspectors, though the pharmaceuticals manufacturing base is not as big as some other states’.
The central and state drugs departments are also required to monitor activities of companies under the Drugs and Cosmetics Act, Drug Prices Control Order, Drugs and Magic Remedies (Objectionable) Advertisement Act, and Narcotic Drugs and Psychotropic Substances Act.
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First Published: Thu, Mar 29 2007. 03 13 AM IST
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