The shadow of spurious drugs is likely to raise apprehensions about the availability of safe and efficacious drugs from India, says Ravi Uday Bhaskar, president, All India Drugs Control Officers Confederation (AIDCOC), Vishakapatnam.
Despite the Indian pharma industry having a domestic turnover, worth Rs. 20,000 crore and exports worth Rs. 10,000 crore, the circulation of spurious drugs is of great concern to all, because it has an adverse impact causing grievous injury and even death at times, due to the failure of intended pharmaceutical intervention.
Trade in spurious or counterfeit drugs are prevalent internationally and it affects both developed and developing countries.
According to Ravi Bhaskar, some of the key reasons that contribute for production of spurious drugs are inadequate number of drug inspectors (only 800 inspectors are there in 600 districts of India), very remunerative trade, technology, lack of enforcement of existing laws or weak penal sections, inordinate delay in courts and lack of interstate coordination.
Other factors being sickness in small scale sector, lack of uniformity in enforcement standards followed by state drug control authorities, lack of coordination between various law enforcing agencies, ill equipped laboratories, corrupt practices, lack of vigilance and intelligence and finally, lack of commitment to the society and degradation of values.
As per the state drugs control authorities, spurious drugs for the period between 1995-2003 varied between 0.24 per cent and 0.47 per cent, whereas substandard drugs for the same period ranged from 8.19 per cent to 10.64 per cent. According to CII figures, the total production of drugs in 2001 valued Rs. 22,887 crore, of which drugs valuing Rs. 4,112 crore were spurious, which accounted to 18 per cent.
Out of 4,933 samples seized in the last three years in Delhi, 61 samples were found as spurious and 203 samples as NSQ. As of Nov 2002, there were only 17 states, which had drug-testing facilities, of which only 6 laboratories have facilities for complete testing of all categories of drugs.
Some of the problems faced by the regulators are inadequate number of inspectors, shortage of funds, poor training in investigating skills, lack of uniformity in implementation or procedures, absence of coordination between the industry and regulators, lack of protection to the regulators, etc.
Mashelkar Committee on spurious drugs has already suggested appointment of more inspectors, promotions to inspectors who detect spurious drugs, creation of intelligence/legal cells, accountability, facilities for speedy communication, adequate testing laboratories, speedy analytical reports, interaction among concerned, creation of better awareness among customers, burden of proof on the accused, scrap licensing, DCA at state and central level be headed by a technically qualified person, creation of special courts enhancement of penalties.
The AIDCOC believes that the problem of spurious drugs cannot be sorted out by appointing committees, but by strengthening the drug control organizations, involving all the stake holders and utilizing all possible resources to make India spurious drugs free nation, he said.