Last month the Haryana police busted a spurious drug manufacturer in Gurgaon. It was using talcum powder to make fake Ciprofloxacin tablets. Although the unit was closed down and its owners arrested, nobody knows what the outcome of the trial will be. Going by the history of such cases, the accused are likely to get off with a light punishment, or perhaps go scot free.

“We have been very lethargic on these issues,” feels Harinder S. Sikka, director, corporate affairs, Piramal Healthcare, who has filed a Public Interest Litigation (PIL) in the Delhi High Court, calling for the implementation of stringent laws against spurious drug manufacturers. “Only a handful of fake drug manufacturers has been brought to book in the last 60 years. Others have mostly got away with small fines and gone back to their lucrative trade,” he says.

According to Sikka, spurious drugs are sold openly in Kanpur and Agra’s dawa mandis (drug markets), and in the Bhagirath Palace market in Delhi right under the eyes of the police.

This is set to change soon. Recently, the government decided to expedite the passing of the long pending Drugs and Cosmetics (Amendment) Bill, 2007. The bill seeks to amend the Drugs and Cosmetics Act, 1940, and proposes a significant increase in punishment, among other things. The current law stipulates a mere five years’ jail term for an offender and a paltry fine of Rs 10,000. But if the amendment comes through, a person involved in the manufacture and sale of spurious drugs is liable to get a prison term of not less than 10 years. A fine of not less than Rs 10 lakh or three times the value of the drugs confiscated, whichever is greater, has also been suggested. The new law will make the offence cognisable and non-bailable too.

The amendments also seek to control the spread of spurious cosmetics, making it mandatory for manufacturers of soaps, creams, shaving products and so on to clearly describe the ingredients on the labels of the products. Even Ayurvedic and Unani cosmetics and medicines have been brought under the ambit of the new law.

“People indulge in the manufacture of spurious drugs because it’s a lucrative business. A stronger legal machinery, a minimum of 10 years’ imprisonment and a steep fine will force many of them to fold up their businesses,” predicts D.B.A. Narayana, managing trustee, Delhi Pharmaceutical Trust.

The government plans to pass the bill in the next session of Parliament. “This welcome move has been due for a long time,” says Sikka. The bill has, in fact, been pending in the Rajya Sabha for more than three years.

An expert committee headed by R.A. Mashelkar, former director general, Council for Scientific and Industrial Research (CSIR), suggested many of the recommendations as early as 2003. The committee had proposed the setting up of a separate Central Drugs Authority (CDA) to oversee the licensing of drug manufacturers and the creation of special courts to try spurious drug-related cases, besides the enhancement of punishment.

“Fake drugs violate Article 21 of the Indian Constitution, which guarantees the fundamental right to life,” says Amarendra Sharan, additional solicitor general of India and a member of the Mashelkar committee. “The government has incorporated most of the recommendations and this bill, when passed, will go a long way in strengthening the hands of law enforcers,” he says.

There are no definite figures on the volume of spurious drugs available in the country. Last year a World Health Organisation-funded study said that around 3.1 per cent of the drugs in the market are spurious. But in February 2008, the Associated Chambers of Commerce and Industry claimed that spurious drugs accounted for a staggering 20-25 per cent of the drugs available in the market. And the market in spurious drugs was worth upwards of Rs 15,000 crores, it added.

“There are no firm data on the spread of spurious drugs. But no matter how small or big it is, it has to be stopped,” declares T.R. Gopalakrishnan, a consultant at the Indian Drug Manufacturers Association (IDMA), Mumbai.

Gopalakrishnan is not impressed with all the new provisions in the bill and says that some of them are likely to be misused. “Government agencies should try to reach the spurious drug manufacturers rather than the distributors who may not know that they are selling fake drugs. Or else innocent people may be victimised while the culprits go unpunished,” he says.

Many are also opposed to the setting up of the CDA to issue licences to drug manufacturers. Right now, it is the state government that carries out this function. “Many small drug manufacturers will be driven out of business as they cannot approach the CDA every time they need a licence. This is nothing but a conspiracy of the big drug companies to monopolise the market,” argues Aloke Chaudhari, secretary, West Bengal Small Scale Pharmaceutical Manufactures’ Association. “The spurious drug manufacturers do not need a licence. Where is the need for a central authority when the state government is in a better position to assess the local situation and issue licences,” he asks. According to Chaudhari, small drug manufacturers account for around 40 per cent of India’s total drug market.

Even the Communist Party of India (Marxist) has opposed this provision of the bill. “If drug licensing is centralised, thousands of small and medium sector drug manufacturing companies all over India will not be able to get their licences and will be forced to close; thousands of workers will lose jobs, and the self-employed will be deprived of their livelihood,” said CPI(M) central committee member J.S. Majumdar in an article in the party’s mouthpiece, People’s Democracy, in March 2008.

But Narayana takes a different view: “Even licensed companies manufacture spurious drugs. With a central authority in place, it will be easy to maintain a database and catch those who sell drugs of low quality,” he says.

During a recent hearing of Sikka’s PIL, the Delhi High Court said that it would wait for the government to carry out the amendments before passing an order on the PIL.

Many others wait as well.