New Delhi: India finally has a law to combat the menace of fake and adulterated drugs, and not all pharma companies are happy with it.
The ministry of health and family welfare notified and implemented on 10 August the Drugs and Cosmetics (Amendment) Act, 2008, significantly increasing the penalty for manufacture of spurious or adulterated drugs.
The amended Act enhances the penalty for manufacture of spurious drugs to a minimum imprisonment of 10 years —which may extend to a life term—and a minimum fine of Rs10 lakh or three times the value of the drugs confiscated, whichever is higher. And it makes the offence non-bailable in some cases.
New regulation: Health minister Ghulam Nabi Azad. Kamal Kishore / Mint
The Bill that was passed by both houses of Parliament in October received President Pratibha Patil’s assent on 5 December.
Although the offences and punishments are now categorized under three types—spurious and adulterated drugs, grossly substandard drugs, and drugs with minor defects—unlike an earlier version, one pharma industry body still termed it “disappointing” because it threatens the prospects of an industry worth Rs75,000 crore by revenue to combat spurious drugs that are estimated to account for 0.3% of this number by value.
Although estimates of the extent of the spurious drug menace vary widely, health minister Ghulam Nabi Azad told the Rajya Sabha on 7 August that drug samples tested all over the country reveal that “approximately 0.3-0.4% of around 40,000 samples tested per annum” are spurious.
Also Read Earlier coverage on spurious drugs
“This Act puts licensed pharmaceutical manufacturers at risk. And the risk is the manner in which a state drug inspector will interpret the Act. Why should they (the government) give power to the drug inspectors to arrest even if the company is a licensed manufacturer? It is not too comfortable,” said T.S. Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industry (Cipi).
However, an office holder at another pharma industry body said the Act does factor in such concerns.
“Most of the guidelines segregate the unscrupulous spurious, fake manufacturers from genuine and bona fide small scale manufacturers who have been facing the onslaught and confusion created by the multinational and large companies to malign the small and medium sector as promoters of spurious drugs,” said Lalit Kumar Jain, senior vice-president, SME Pharma Industries Confederation (Spic).
India’s Central Drugs Standard Control Organisation (CDSCO) has undertaken a survey to assess the extent of spurious drugs in India.
Close to 24,300 samples of 61 brands of drugs across nine therapeutic categories and manufactured by 30 companies were collected from 100 pharmacies.
The health ministry is also in the midst of formulating a whistle-blower policy under which it will reward people who provide information on the manufacture and trade of spurious drugs.
However, there are also concerns that the the new Act gives too much power to the drug inspectors at the state level. Still, it does lay down guidelines for the state drug control organizations, clearly stating standard operating procedures to examine and process various violations of the law.
“I honour the industry’s worries that now with the bail provisions being so stringent, genuine manufacturers might feel the heat. But the clandestine operators surely have to be put behind bars. So, this Act has to applied very judiciously...based on facts and investigative proof,” said Manoj Tongra, a drugs control officer in Rajasthan.