Revamping legal mechanism alone can’t stop spurious drug makers

Excessive pressure from global agencies pushed India to make significant changes in the Drugs and Cosmetics Act that will now subject perpetrators of spurious drugs to harsher punishments. From the times when offenders found guilty of manufacturing spurious drugs were allowed to go free with a minuscule penalty to now, when a 10-year prison and a hefty charge will be slapped, it is all a move in the right direction.

Empowering the police to arrest manufacturers and distributors of spurious drugs and place them as cognizable offenders will be a definite hurdle for those who sell drugs that can kill or maim gullible patients.

The industry itself has been much worried about the menace of duplicate drugs but none came in the open to point out that fake clones of their own big brands were sold in millions. The effect would have been disastrous for their sales as brand sales would have been impacted and so companies preferred to lobby under associations on such critical issues.

Spurious drug manufacturers have been a smart lot though. They have been able to copy big brands with impunity and remained untraceable. They have been able to keep pace with every change that companies have been making to protect their brands. From putting holograms to other innovative means of packaging, every attempt to prevent spurious brands from flooding the market had failed.

Fake drugs racket may not be entirely due to the lack of adequate legal framework. There are questions pertaining to the implementation of the law that need to be answered.

In the northern belt, where most cases of spurious drugs have been detected, the drug authorities may not have dealt with the subject seriously. Stories abound were small tablet factories have cropped up that are churning out all kinds of products that may not be placing any controls over the quality of drugs. Are these micro units eligible to produce medicines? Do they have the right licences to manufacture the products? Are they submitting the bare minimum bioequivalence data before getting into production of such sensitive products that affect patient lives?

For long, the government has been contemplating setting up the central drug authority that will be equipped with powers and resources matching all other international drug agencies. The powers to issue drug licences was to be managed by the new authority but the state drug administrations raised objections to creation of such body. Like every good move is resisted by vested interests, this too was decently buried and we continue with the old norms of state-wide licensing authorities.

A brand approved in one state may be sold in another state without any restrictions and the manufacturers of many questionable products may have to deal with any objections at all. Our systems have lapses that need to be corrected before we incorporate new legislations and conclude that the older ones were ineffective.

International agencies have strong lobbying mechanisms. Loosely framed laws in India on subjects as crucial as medicines give such bodies enough ammunition to go against Indian companies and spread disrepute.

Some of the best known Indian companies like Cipla and Dr Reddy’s have faced problems in the past when EU countries blocked their consignments stating that these companies have contravened the local patent laws. In its recent move to prevent Cipla from marketing copies of Nexavar — which is a kidney cancer drug — Bayer termed that Cipla’s product may be spurious if allowed to be marketed in India. This shows how local laws can be interpreted and the safest medicines can be clubbed as spurious.

The WHO, too, recently attempted to include generic drugs as spurious in its latest definition but timely intervention from the Indian government helped. According to estimates put by international bodies, the extent of spurious drug trade in India goes beyond Rs 5,000 crore.

That means an extremely big proportion of the Indian drug market has spurious products in active circulation, unbridled. If that number is accepted by the government authorities, a high-level intervention programme is necessary to alleviate a dangerous crisis situation.

None of the revamped legal mechanisms can work if the manufacturers of fake drugs are not weeded out. Behind every criminal exercise like production of spurious drugs, there are many powerful people who protect the wrong doers.

Pillman is an executive closely linked to the global pharma industry