Less than a month after completing its own study in India to estimate the incidence of counterfeit and spurious drugs in the local market, the World Health Organization (WHO) is willing to extend its financial as well as technical support to a proposed countrywide survey on fake drugs mooted by the Union ministry of health and social welfare.
The ministry last month announced that it will conduct a nationwide survey to ascertain the presence of fake drugs in the market by collecting 1 lakh to 1.5 lakh samples from across the country.
Valerio Reggi, WHO’s co-ordinator for medicines regulatory support, technical cooperation for essential drugs and traditional medicines, said there are no constraints on the organization to offer help to the government of India to get an accurate picture on the fake drug market here.
“We will extend our help to this project by all means if the government needs it as it will help the country to prove whether these so-called projections are real or not, even as the recently concluded survey conducted by the International Pharmaceutical Federation on behalf of WHO, too, gave only a projection of 3%,” he said.
Reggi was in Mumbai to attend a seminar organized by the Confederation of Indian Industry, an industry lobby group, on counterfeiting.
“No one has a definite figure of fake drug prevalence in any of the markets in the world. And this is not the problem of developing countries alone. It also exists in developed countries,” he said. “Hence, an extensive study like the one which is proposed in India will help not only to tackle the issue here, but will also help other countries to follow same kind of measures to find and fight the menace, if any.”
Apart from revenue loss at leading drug firms, counterfeit and spurious drugs do not deliver desired results in patients under treatment.
The chance of the government seeking WHO’s help, however, are slim. The drug controller general of India (DGCI), M. Venkateswarlu, who has prepared a comprehensive plan for the fake drug survey said: “We have a rough estimate of Rs2.5 crore expected to be incurred in the project, and the industry has already offered their help in testing and analysis of the collected samples.”
The office of DGCI, which was earlier planning to appoint a non-government organization for collection and logistics of the samples from across the country, has now instead set up six zonal cells within the regulatory department to coordinate with 300 independent consultants, who have been given the job of collecting medicine samples from wholesale and retail trade outlets, pharmacies, dispensaries, hospitals, etc. “These 300 consultants have been contracted for the work,” said Venkateswarlu.
The countrywide survey of fake drugs, which Mint first reported on 18 July, was initiated in India following studies that threw up wide ranging estimates of the prevalence of fake drugs in India: between 3% and 30%. Such studies, together with reports of counterfeit drugs—defined as those violating patent and copyright rules by, for instance, mimicking packaging and brand names— originating in India and sold in markets as far as Africa and Europe, have tarnished the image of the Indian drug sector.
“The term fake drugs is being widely misunderstood in the country as well as overseas markets as (only) spurious drugs,” said Reggi. The majority of fakes are counterfeits, which contains active pharmaceutical ingredients, and are not really harmful, he added. “Counterfeits are the brands which are sold in the market by faking the name and label of established brands of drugs mostly prescribed by the physicians. And it is often found that the size of the counterfeit and spurious drugs market in countries like India is exaggerated,” said Reggi.
In a series of articles this year that looked at lax regulation of drug manufacturing and drug trials in India, Mint has highlighted the ease with which fake drugs can be obtained, as well as delays and inaction on the part of regulators in dealing with the issue. A 2005 Bill to tighten regulations, awaiting lawmaker clearance, is expected to be introduced in the Parliament in the current session.