Over the past couple of weeks, enough has been going on in Chennai to get its residents a little worried about whether they are getting genuine, quality drugs when they go to a pharmacy.
The Directorate of Drugs Control, as part of its continuing regular inspections, stumbled upon a racket that was ingeniously re-introducing expired drugs back into the market. M. Bhaskaran, director, Drugs Control, said “We had some tips and pursuing that, we conducted surprise raids at least at 15 wholesale and retail shops on March 10. During the course of the investigation, the DIs [Drug Inspectors] noticed that a wholesaler G.H.Pharma had boxes of Renerve capsules with tampered expiry dates. The firm had also sold these capsules to other pharmacies and super stockists.”
The trail eventually led to Sanjay Kumar who was a resident of Aravamudhan Street, Chennai. When a raid was conducted in that place, they seized cartons of drugs past the expiry date, injections, syringes and vials meant to be used in government hospitals. All these stocks were seized with the help of the police.
“The modus operandi was quite simple. All drugs with dates that have expired have to be returned to the manufacturer who destroys them. In this case, a driver of the pharmaceutical company making the drug (Grandix) passed on stocks of these expired drugs to Ravi of Kodungaiyur, who in turn supplied them to a pharma agency in Chennai, and Sanjay Kumar,” Mr. Bhaskaran explained. Chemicals were used to erase the original expiry date and then, fresh dates were printed before they sent the drugs back to the pharmacists, and then on to the consumers.
According to Dilip G Shah, Secretary-General, Indian Pharmaceutical Alliance, there is a standard operating procedure for expired drugs that reduces the incentives of wholesalers or chemists to attempt to sell them. Six months before expiry they can intimate the company of forthcoming expiry and the company will issue 100 per cent credit for product returns. Manufacturing companies, he said, will not put stock into the market that has less than three months left before expiry. “Ultimately this is a trade related problem, not an industry issue,” he said.
As far as the Act is concerned, there is a clear chain that will take the expired drugs from the retailer back to the manufacturer who is tasked with ensuring the drugs are safely destroyed, Principal Secretary, Health, V.K.Subburaj explained. The Drugs Control Office has also sent a notice to Grandix, the manufacturer of Renerve, in this case, because of the involvement of the driver.
Porous supply chains have proven problematic as the experiences of the recent weeks have shown. R. Desikan, of the Consumers Association of India, pointed to the difficulties pharmacies and consumers have identifying medicines that had been tampered with. “There is no way organisations like ours can find out, you have to test the product,” he said. Between the State distributor of a medicine lie sub-distributors, collectors and pharmacies so there is room for misuse within the systems, he said.
Hidden behind the media stir caused by the recent drugs haul is even more upsetting information. The Drugs Control office has unearthed over the last year alone, several cases of fake drugs (drugs not made by the manufacturer but riding on the brand value) were unearthed and seized. Drugs such as Primolut – N (hormonal), and Benadryl Cough syrup were found to be fake. While from the packs itself it would have been difficult to tell if the drugs were fake, but a chemical examination leaves no doubt that they are indeed not the original.
Among the problems plaguing the system is a huge shortage of Drug Inspectors. Mr. Subburaj said no recruitment had been done in the last 10 years. Only as late as last month, over 20 people were recruited against vacancies. “But we are even trying to get more posts sanctioned at this juncture. There are at least 4,000 pharmacies just in Chennai, and until recently, only 50 DIs for the entire State. These DI's also do not have any penal powers.”
However, Mr. Bhaskaran says the key is not to blow the issue out of proportion. “There is a general fear among the public thanks to media coverage. We would like to reassure them that this is not a widespread problem. We are hearing that drugs are being dumped in different parts of the State on mere suspicion that they may be fake. There is no need to panic,” he adds. The State pharma helpline for consumers is 24338421.
"This report was corrected on March 27, 2010"