Drug registration in India needs to be strengthened to ensure that all drugs that are, domestically produced as well as those imported are assessed for safety, efficacy, and quality before they are available to the consumers. To achieve this, drug regulatory authorities should develop significant capacity and know-how. Political pressures prevent drug inspectors from investigating counterfeit and substandard drugs and prosecuting counterfeiters. Inspectors should be given the rights to enter manufacturing or packaging premises collect samples for tests, and not conduct sale of the drugs until they check the results of the tests.

Having sophisticated tools for investigating counterfeit medicines is required if any progress is to be made in curbing the menace of spurious drugs. The use of near-infrared spectroscopy (NIRS) for rapid, on-site and non-destructive identification of counterfeit pharmaceuticals has been well documented.²¹ Upgradation of testing laboratories and training of scientific personnel in these laboratories for quick analysis of drug samples and the setting up of special courts to deal with summary trials would help control the entry of spurious and substandard drugs in the supply chain.

Organisation of Pharmaceutical Producers of India (OPPI) along with the IFPMA and the Pharmaceutical Security Institute (Geneva, Switzerland) is planning to set up an intelligence network to counter the counterfeit drugs trade. Glaxo is going in for holograms, special ink, printed/locked capsules, biocodes and embossing of tablets with a logo, explains P S Khanna, resident director of OPPI in Delhi. Many are also seeking the help of private detective agencies or using marketing staff to monitor the trade.

Major Indian pharmaceutical companies — Alembic, Cipla, Dr Reddy's Labs, Lupin, Nicholas Piramal, Ranbaxy, Sun Pharmaceutical and Wockhardt have joined hands to form the Indian Pharmaceutical Alliance (IPA) to look into the counterfeit trade. Their anti-piracy task force looks especially into complaints regarding counterfeit drugs.²² The setting up of an inter-ministerial Standing Committee would also help check this burgeoning trade (see box: New committee).²³

India's reputation as the hub of counterfeit drug exports may have a serious consequence to the industry in the future. The current practice of large industries contracting with small-scale units for smaller "jobs" indicates the limited capacity of the producers resulting into poor quality of the drug. Additionally, with no recall policy in the pharmaceutical sector, the drugs with expired data of use would persist in the market until they are bought out. Small-scale units that undertake production on a contractual basis from the large scale companies are more than willing to produce large quantities of medicines especially due to the insecurity business, and thereby their income.

Internally, DCA and pharma companies should monitor the movement of every batch of every drug. A chain of command that is monitored by the pharma company and strong punitive measures by DCA will ensure that fake drug markets are stamped out. A recent Supreme Court hearing in the case of Venu Veterinary Division, has ruled that a dealer in drugs and cosmetics could be prosecuted for selling spurious or substandard goods. This important hearing sets the distributor and manufacturer apart, with the Supreme Court stating that there is no prohibition in the law which states that a dealer cannot be prosecuted for sale of spurious medicines or cosmetics below the prescribed standard of quality without the manufacturer also being made a co-accused.²⁴ What is needed is more stringent laws like this to deal with the burgeoning counterfeit mafia trade.

Government is contemplating tightening the law against spurious drugs flooding the market and may bring a bill to amend the provisions of the existing laws for the purpose. "Law is there but it is not adequate. We must strengthen the law as spurious drug manufacturers are the real killers and antinationals, "Health Minister Shatrughan Sinha said. However, there are certain drawbacks in the existing law. If spurious drugs are caught, the onus to prove that the medicine did not belong to them lies with the manufacturers of genuine medicines," Sinha said.

One way to track the prevalence of counterfeit drugs is to define the points of entry of drugs into the market. Rigorous inspection and surveillance should be conducted in collaboration with customs and police to prevent and control smuggling. South Asian and Indian ports are notorious for exporting spurious drugs to Africa, Russia and South East Asia. Custom officials are not trained to distinguish between drugs, and therefore are incapable to prevent smuggling of counterfeit drugs. Combating counterfeit and substandard drugs at the national level is thus a shared responsibility involving the relevant government agencies, pharmaceutical manufacturers, distributors, health professionals, and the general public. Making them realise how their interests are threatened would help focusing their attention on the issue.