The Union government will introduce a new Bill with severe penalties against makers and sellers of fake and spurious drugs in the next session of Parliament, as part of a package of five health and pharmaceutical legislations aimed at tightening regulations related to drug approvals, manufacturing, functioning of hospitals, practising doctors, diagnostic centres, and even paramedical staff in the country.
The most crucial one among all the proposed legislative changes is the amendment to the Drugs and Cosmetics Act, 1940, which will sharply increase penalties for those involved in spurious and counterfeit drug trade.
The amendment sets a minimum punishment of 10 years’ imprisonment and a fine not less than Rs10 lakh or three times the value of the fake drugs seized, and makes violations a cognizable offence mandating immediate action by administrators or judicial authorities.
The existing law prescribes imprisonment of at least five years and a minimum fine of Rs10,000. Transgressions of rules are bailable currently but the new amendment plans to make offences non-bailable in most instances. Also, violations of the current law are not seen as cognizable offences.
The amendment Bill had been languishing with the government for over two years.
It had been introduced in Parliament once earlier under the previous Bharatiya Janata Party-led National Democratic Alliance regime, but wasn’t approved by lawmakers.
Problems with counterfeit drugs as well as delays in passing laws against the Bill have been featured in a series of articles on drugs and regulation in Mint earlier this year.
“It (the Bill on counterfeit drugs) is coming in this monsoon session. We wanted to introduce it the last time too, we were prepared for it, but we didn’t have a chance as the session had wound up a little earlier,” Anbumani Ramadoss, Union minister for health and family welfare, told Mint on the sidelines of a conference announcing the third AIDS control programme. The next Parliament session, commonly referred to as the monsoon session, is expected to start at end of July or early August.
Prafull D. Sheth, vice-president of the International Pharmaceutical Federation, a watchdog body set up by drug companies, and one who has investigated the impact of counterfeit drugs for long years, is not surprised the ministry has finally come around to placing the Bill.
“The ministry knows that it is going to come under severe criticism for this menace and must have been preparing for this,” Sheth says. “It will be a very lively and keenly-watched session.”
Health and drugs administrators call fake drugs as “silent killers”. There is no good estimate of the number of people affected or the share of these drugs in the Rs55,000 crore Indian pharmaceutical sector. Some government studies peg it as low as 0.5% of the total drug sales while others, such as an estimate by trade body Assocham, put it at 30% of all the drugs sold in the country. Industry insiders say every top-selling drug in the country has a fake version.
Other legislation to be introduced in the monsoon session of Parliament includes one that will enable the setting up of a regulator with wide-ranging powers across the drugs and health care industries. “The other Bills coming up this time will be those on the Central Drug Authority (CDA), clinical establishments and another on setting up councils,” said Ramadoss. “The HIV/AIDS Bill is (also) something we’ll try for.”
The Bills will pave way for the CDA, a national drug regulator on the lines of the US Food and Drug Administration, which will have sweeping powers in regulating drug approvals, manufacturing licences, clinical trials, medical devices and even traditional medicine systems, and another for quality standards for clinical establishments.
According to a study by industry body Ficci and consulting firm Ernst & Young, privately-run hospitals will more than double revenues to nearly $36 billion (Rs1.44 trillion) by 2012. Medical equipment industry too is expected to grow from $2.17 billion in 2006 to touch almost $4.97 billion by 2012. But such businesses are loosely regulated. The proposed legislations will put these mushrooming segments, including doctors’ clinics, nursing homes and even diagnostic centres, under the regulatory scanner.
The fourth Bill in waiting is the Paramedical and Physiotherapy Councils Bill, which will set up councils for physiotherapists, radiographers, laboratory technicians and paramedical staff. “The council will make recommendations to the industry and suggest actions for the government. It’ll also work on course curriculum of these professional courses,” said Naresh Dayal, secretary in the health ministry.
The last Bill, still awaiting the nod from the Union cabinet, is the HIV/AIDS Bill, aimed at ending discrimination against HIV-positive people.