The Hindu : National : Study to probe extent of spurious drug industry

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Thursday, Sep 20, 2007
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Study to probe extent of spurious drug industry

Sarah Hiddleston

“35% of drugs made in India no better than talcum powder”

Anbumani hopes the study will end speculation on ethics of manufacturing practices
Bill to create Central Drugs Authority now before a standing committee

CHENNAI: The government has decided to launch a major new study into the extent of the substandard and spurious drugs industry in the country, Health Minister Anbumani Ramadoss told The Hindu in an interview.

Over the next three months, the government plans to test around 300,000 samples of drugs used to treat specific medical conditions, including cardiovascular diseases, diabetes and cancer. Dr. Ramadoss hopes that the study, which will cost the Ministry of Health and Family Welfare an estimated Rs. 5 crore, will put an end to speculation about ethics of manufacturing practices that had damaged the reputation of India’s multi-crore pharmaceutical industry.

When an article appeared in The Lancet in 2001 citing World Health Organisation statistics that 35 per cent of all drugs made in India were nothing better than talcum powder and, worse, that a fifth of these contained wrong or harmful substances, it unleashed a barrage of media investigations. The government found itself unable to counter these charges although the WHO denied the statistics in question.

Until now, the government has relied on nearly 40,000 samples handed over from State laboratories to the expert committee headed by the former CSIR director-general, R.A. Mashelkar, which showed that less than 10 per cent of the drugs in the market were substandard and less than 1 per cent spurious. But the Indian media reported cases of fake paracetamol, thyroid hormone, insulin and antibiotics this year.

Ranjit Shahani, head of the Organisation of Pharmaceutical Producers of India, says that even assuming there is only one batch of one counterfeit product in the market, 300 lives could be lost in a day. “That’s one jumbo jet.” Understanding the scale of the problem at least makes for a start towards containing it.

Regulatory mechanisms

Effective management, Dr. Ramadoss believes, requires change in regulatory mechanisms, change in legal and penal mechanisms and capacity building at both State and Central levels. The government’s bill to create an independent Central Drugs Authority of India (CDAI) along the lines of the United States Food and Drug Administration (the details of which were carried in The Hindu on September 7), is now before a standing committee that will make its recommendations in three months.

The government has already begun modernising State and Central testing laboratories, launched reorientation training for all staff and increased the number of drugs inspectors using the Rs.400 crore funding given by the World Bank for capacity building in food and drugs regulation.

But while the creation of the CDAI and other capacity building measures might help to counter the problem of substandard drugs, they will not do much for the problem of counterfeit or spurious drugs. Unlike substandard drugs, which result from lax manufacturing in licensed units, counterfeits are deliberately and fraudulently mislabelled with respect to source or identity and may include insufficient quantities of the required ingredients, harmful or wrong substances, or completely inactive substances such as chalk.

Changes in legal and penal mechanisms have not as yet been recommended to the Cabinet as experts are still studying them, Dr. Ramadoss said. The proposed amendments would increase the fines for manufacture and sale of counterfeits from Rs. 1 lakh to Rs. 10 lakh, increase the prison sentence from 5 years to life, fast track legal cases by instituting special courts and make offences cognizable so that the police can act directly on complaints.

“If there is no provision for severe punishment in the law, a new structure won’t deter manufacturers and sellers of spurious drugs. Much would depend on the fear that the regulatory authorities can create,” said D.G. Shah, Secretary-General of the Indian Pharmaceutical Alliance.

Mr. Shahani believes additional measures are necessary.

He recommends accelerating the passage of the penal bill, creating dedicated cells in all law enforcement agencies, conducting consumer awareness campaigns, enforcing packaging designs that incorporate holographs and introducing radio frequency identification technology.

Counterfeit drugs are not just fakes, he said, “with medicine, it’s the perfect murder.”

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