Calcutta, Aug. 4: Stop before you pop that pill, since it could well be nothing but chalk powder, flour or recycled drugs well past their expiry date.
One in every four strips of tablets bought over the counter could be spurious, sub-standard, counterfeit or fake, according to industry estimates, and, because of their inadequate potency, erode the immunity of those who consume them.
According to a World Health Organisation (WHO) survey, 35 per cent of the world’s spurious drugs are produced in India, which has a Rs 4,000-crore fake drugs market.
With global R&D leaders turning the heat on the Indian drug industry and quality-conscious generic-drug manufacturers lamenting that they are being tarred with the same brush as the unorganised sector, the Confederation of Indian Industry (CII) has padded up to combat the menace.
“There are more than 20,000 small and big drug manufacturers in this country, and a WHO certificate for good manufacturing practices is a must for each of them. A strict vigil will see at least 50 per cent of them failing to cross the bar,” says Harinder S. Sikka, senior president, corporate affairs, Nicholas Piramal, and convener of the CII task force on spurious drugs.
Union health minister Sushma Swaraj advocates death penalty for the spurious drug-maker and plans to bring a legislation in Parliament in the monsoon session.
But, as dealing in spurious drugs does not constitute a criminal offence as of now, and with a mere 3 per cent conviction rate, is anyone scared'
The CII task force, which met Swaraj last month with a set of recommendations to tackle the threat, had sought “zero tolerance” for offenders.
“First, manufacturing and selling of spurious drugs should be made a non-bailable criminal offence,” says Sikka. The pharmaceuticals industry has proposed amendments to the Drugs and Cosmetics Act to make fake-drugs offence similar to narcotics crime.
With the Mashelkar committee, formed last year to recommend control strategies, seeking a three-month extension to its July 27 deadline and the health ministry failing to come up with an action plan yet, the CII initiative has found support from all corners.
The Organisation of Pharmaceuticals Producers of India (OPPI) and the Indian Drug Manufacturers Association (IDMA) have rallied under the CII banner. CII believes government regulators — for every 100 manufacturing units, there is only one inspector — are hand-in-glove with the counterfeiters.
“It’s unlikely they don’t know what’s happening. They have simply converted the problem into an opportunity, making it easy for marginal and small players to substitute the fake for the real,” says a task force representative.
An independent probe done by another task force of the Indian Pharmaceutical Alliance, a coalition of 10 drug majors, had resulted in the arrest of 51 people in two years and seizure of Rs 12 crore worth of spurious drugs.
“The effort was worth more than what the drug inspectors have achieved in the last 30-40 years,” says Sikka.
Ranjit Shahani, vice-chairman, Novartis, and president of OPPI, calls it “a perfect crime”.
Says Shahani: “The entry barriers are so low and the trade so profitable that from gangsters to grannies, everyone gets involved. Since manufacturing costs of fake drug producers are ridiculously low, they are able to create well-financed defences and sophisticated DTP (desk-top publishing) set-ups to reproduce exact replicas of new packaging labels and holograms in no time.” While some spurious drug manufacturers do not bother to register with the drug controller and produce clandestinely, others play Jekyll and Hyde —making genuine medicines with proper licences by day and fake drugs at night at the same facility, says Sikka.
CII feels the axe should fall on the chemist, too, since “between manufacturer and retailer, margins often swing wildly between 1,000 to 5,000 per cent, which the organised sector simply can’t afford”. OPPI has commissioned another independent survey to gauge the reach of spurious drugs in various zones. “Our experience shows counterfeiters prey more on the vulnerable semi-literate and illiterate belts where a patient always dies of the disease and not of the drug,” adds Shahani.