Bad medicine

Stronger laws and their effective implementation are necessary to check the worrying growth of spurious medicines

Akash Bisht and Sandeep Yadav Delhi

The ministry of health is worried. The spurious drugs' market in the country is burgeoning and health officials remain clueless on how to wage the battle. Conservative estimates peg the turnover in spurious drugs to Rs 6,000 crore. This ever-growing industry is a threat to health and demands suitable laws to stem the illicit trade.

SK Arya, joint director, Indian drug manufacturers association (IDMA) holds weak laws, with loopholes, as the main cause of the flourishing spurious drugs business. 'People who indulge in the spurious drugs trade have all the right contacts and even if they are nabbed it is very difficult for the police to make a case against them because of the cumbersome procedure involved,' deplores Arya. The problem has also spilled across the border with Afghanistan, Nepal and Nigeria emerging as lucrative markets for spurious drugs made in India.

Economically, India's pharmaceutical industry is its strength, growing steadily at the rate of 10 per cent per annum for the last decade. Compared to a time when it was a net importer of formulations, it now exports most of them. In the boom, manufacturers of substandard and counterfeited drugs slip in.

They find a way through the rules and laws relating to the handling of spurious drugs, which are not in accordance with such large-scale production of medicines.

In the late 1990s, the supreme court, national human rights commission and members of parliament were continuously seeking tightening of the prevailing drug regulatory system. The government had already adopted several new policies and constituted multiple committees to keep a check on the increasing business of fake drugs. The new pharmaceutical policy approved by the cabinet laid stress on monitoring the quality of drugs. The Haathi committee suggested setting up a new drug regulatory authority. Then the Mashelkar committee, named after the director-general, council of scientific and industrial research (CSIR) RA Mashelkar, was formed and it recommended the establishment of a first class drug regulatory infrastructure and severe judicial action against those found guilty. The committee also suggested constituting special courts throughout the country to try spurious drug cases and to establish a network of informers. It further observed that a comprehensive review of the drugs and cosmetics act, not reviewed since inception and has been amended a few times, is mandatory. It advocated that a focused approach is required to amend the act from time to time to make it more effective.

Lack of appropriate legislative measures and poor coordination between various law enforcement agencies has helped the racket of spurious drugs. There have been numerous instances when media has reported seizure of large hauls of spurious drugs. These reports failed to grab the attention of the government.

When confronted with the issue of spurious drugs in parliament, the union health minister, Anbumani Ramadoss explained that to ensure efficient information exchange between drug regulatory officers in the country, in respect of licensing, sampling, prosecution, and so on, a countrywide computer networking project has been undertaken by the central government. He was sure that this would enable government to regularly monitor enforcement activities and recommend corrective measures. The minister said that the government plans to increase the number of drug testing facilities and upgrade the existing laboratories in assistance with the World Bank. Without further explanation, it remains elusive as to how these measures will resolve the problem.

Apart from patients, the worst affected by the gigantic illegal operation are drug  manufacturing companies, which steadily lose out because of spurious drugs. 'Private companies are not only concerned with the growing market of spurious drugs, but also fear their brand name getting tarnished,' attests Arya.

Companies such as Ranbaxy, Novartis and Cipla are very watchful when it comes to counterfeiting their drugs. Though they keep monitoring the sale of their drugs, their ability to curb the threat is weak. Pharmaceutical companies have gone to the extent of hiring private detectives in trying to nab the manufacturers of these drugs. They have been successful to some extent but could not follow it regularly due to excessive expenditure it required. Pharma companies complain that lack of efficient judiciary and rigorous laws are just helping the spurious drugs' manufacturers.

Attracted by huge profits, retail chemists knowingly stock a fake product of an established brand. Without the support of the retail pharmacies, no spurious drug can reach the consumer. 'We always advise customers to take cash memos because it minimises the chances of chemists selling fake drugs to them,' insists Gajanan Wakankar, executive director, IDMA. It is difficult for the retailer to sell spurious drugs with cash memos, as they have to document each detail and furnish the same to pharmaceutical companies.

The Mashelkar report has gone to the extent of recommending the death penalty for the sale and manufacture of spurious drugs that causes grievous hurt or death. In last decade there have been multiple instances of spurious drugs being seized but there are very few instances where the guilty have been penalised. 

It is a well-known fact that spurious drugs are being sold at Bhagirath Place in Delhi and some parts of the old city but till date there has been no action taken against the retailers because of lack of evidence. There also have been reports of spurious drugs' wholesalers in the outskirts of Delhi-Ghaziabad and Agra. The procedure for conducting raids is predictable. Once samples are collected they are sent off far because of the shortage of drug testing laboratories in the country. Suspect drugs in Delhi go to Kolkota, and from there it takes two-three weeks for the report to return to Delhi. Time enough for the manufacturers to escape. Only the peddler is caught leaving the main culprit scot-free.

A small percentage of retailers in Bhagirath Place are involved in the contraband venture. 'More are involved in rural India where hardly any checks or raids that are conducted,' confides Amarjeet Chhattarpal, a Delhi-based distributor. If operators can escape in the heart of the capital, it is no wonder that those in the hinterland find a haven.

Unscrupulous dealers find rich hunting grounds in government hospitals in rural areas. Government issues tenders for supplies of medicines in hospitals, and the lowest bidder is handed the contract. Spurious drugs' manufacturers cut everyone else down in bids, quoting prices that are lower than the cost of the ingredients needed for the medicines. 'Drugs that are meant for government hospitals are stamped with a 'G'. Most of these medicines on a number of occasions have turned out to be fake, but no action has yet been taken to deal with the problem,’ informs Wakankar.

According to the drugs and cosmetics act, 1940, spurious drugs fall under four categories: drugs imported under a name which belongs to another cosmetic; if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive; if the label or container bears a fictitious company name; if it is an imitation of, or is a substitute for, another drug. There are different laws that deal with these categories making the judicial proceedings even more complex. The penalties are different for these categories and it takes years for judicial proceedings to finish.

To make it easier for the racketeers is the tardy investigation by the authorities. Recently, the Delhi high court in its decision directed immediate registration of first information reports (FIR) against manufacturers on the seizures of spurious drugs. The court also directed the government to engage services of competent lawyers in resolving all pending cases against these manufacturers. 'When we inform the authorities about the spurious drugs being either manufactured or stored the authorities work at a very slow pace and many officers have to be informed before conducting a raid,' grumbles Wakankar.

New laws will definitely help authorities in nabbing these criminals but the real test for the authorities would be to implement these laws effectively so that the end user, the patient, does not fall prey to these drugs. 'All the pharmaceutical companies should have a common platform, a strategic alliance with private and government agencies (Drug Controller of India, Central Bureau of Investigation and others), for proper planning and thereby, take proper feedback from the market about these drugs. Also, strict punishment should be awarded to the guilty, the manufacturers of these fake drugs. There should be no pardon while awarding a judgment as they are playing with the lives of many and hence, a change is sought in the Indian constitution,' concludes Rajkamal Singh Bhatia, national distribution manager, Panacea Biotech Limited.