Pharmacy Industry News: Taskforce set up to check spurious drugs
Taskforce set up to check spurious drugs
A 12-member committee headed by the Indian Council of Medical Research ( ICMR) director-general V M Katoch has been constituted to asses the quantity of spurious drugs floating in the market using anti-counterfeit technologies and recommend measures to address the issue.
The drug taskforce will be looking into step needed to promote indigenous production of bulk drugs and preventing the take over of Indian pharma industry by multi-national companies.
The taskforce has representatives from National Pharmaceutical Pricing Authority, Department of Industry Policy and Promotion, Indian Drug Manufacturers Association, Mumbai, Indian Pharmaceutical Alliance, Mumbai, Organisation of Pharmaceutical Producers of India, Mumbai, among others.
“The taskforce will submit its report within a time period of three months. It will recommend measures to tackle the problem of spurious drugs — use of anti counterfeit technologies as well as consider and advice on any other issue incidental to the above,” said a health ministry official. The constitution of the taskforce comes close on the heels of Union health minister Ghulam Nabi Azad recently meeting with the drug manufacturers.
According to health ministry’s estimates, 5.6% of drugs in the country don’t adhere to standard quality.
OxyContin prescriptions by Ontario MDs vary greatly, study finds
Some doctors are writing significantly more prescriptions for such powerful painkillers as OxyContin than their colleagues, a new study suggests — a practice some are blaming on the influence of pharmaceutical companies.
A new study highlights the issue of opioid-related deaths, which have surged in recent years to the point where they are now considered more common in North America than deaths from HIV. The report, which looks at data from 2006, was published in this month’s issue of Canadian Family Physician.
It found Ontario’s most frequent opioid-prescribing family doctors wrote 55 times more prescriptions for the narcotics than physicians who prescribed the drugs the least.
Those doctors handing out the most prescriptions had the highest numbers of patient deaths linked to the drugs, according to researchers at St. Michael’s Hospital and the Institute for Clinical Evaluative Sciences, both in Toronto.
“We know that the drugs are useful in particular patient populations, and we also know that they’re potentially very dangerous,” said the study’s lead author, Dr. Irfan Dhalla, who called the variation in prescription rates striking.
“The drugs need to be used and prescribed with great care.”
A 2009 report by the College of Physicians and Surgeons of Ontario found that opioid-related deaths in Ontario increased 49 per cent between 2002 and 2006.
Deaths linked to oxycodone — the active ingredient in OxyContin, also known as Hillbilly Heroin — shot up 240 per cent between the same years.
Dhalla is calling for better education of physicians when it comes to appropriately handing out the drugs.
“I think education needs to occur at all levels,” he said. “Medical students don’t receive enough education about these issues, and until recently at many universities, the education was being delivered — at least in part — by people who have ties to the pharmaceutical industry and were presenting information that was potentially biased.”
St. Michael’s physician Dr. Philip Berger pointed to pressure from the pharmaceutical industry as a reason for the spike in prescriptions.
“It is important to recognize that one reason opioids are prescribed so often is that the pharmaceutical industry has marketed these drugs very aggressively,” Berger said in a statement.
He later told Postmedia News that pharmaceutical companies’ “unethical and unbelievably aggressive marketing” practices are unfairly influencing Ontario’s overstressed family physicians.
“With that nudge and push from the pharmaceutical companies, they may be more eager to just prescribe a drug without exploring other methods of relieving pain,” he said. “They make it appear that it’s normal to prescribe medications in situations where they should not be.”
The University of Toronto revised the curriculum for one of its pain-management courses in 2010 after a 371-page pain-management book funded and copyrighted by Purdue Pharma, the manufacturer of OxyContin, was distributed to students in the course.
From 2002 to 2006 the course was funded in part by donations from drug companies — a practice the U of T curtailed in 2007.
Purdue Pharma, the manufacturer of OxyContin, could not be reached Tuesday for comment.
The study looked at prescription records for Ontarians aged 15 to 64 who qualified for provincial drug coverage.
In 2006, 166 of the 408 people in the province whose deaths were linked to opioid use received at least one prescription for the drugs in the 12 months prior to their death.
Of that group, 102 received their final prescription before death from a family physician.
Sixty-two per cent of patients who died while in the care of a family physician had a doctor who was among the group of most frequently prescribing physicians.
According to the Ontario government, between 1991 and 2009 the number of prescriptions for oxycodone skyrocketed 900 per cent.
The drug is about 1.5 to two times more powerful than morphine.
The Ontario government responded in November 2010 with the Narcotics Safety and Awareness Act, which will allow the Ministry of Health to monitor the prescription of opioids and stop addicts from obtaining drugs from multiple doctors at the same time.A spokesman for the Ministry of Health said the department is currently developing plans to work with the health-care sector to educate doctors on appropriate prescribing methods as part of its narcotics strategy. There is no timeline for the launch of the education program.
Health ministry sets up taskforce to address issues of pharma industry
The Union health ministry has constituted a taskforce to address issues faced by the pharmaceutical industry and evolve a long-term strategy for the sector. Prevention of takeover of domestic pharma companies by MNCs is one of the areas that the taskforce will look at.
The quantum of foreign direct of investment (FDI), the route through which it can come into the pharma industry and takeover of domestic firms by MNC giants have been among the burning issues in the recent past for the sector.
The 12-member taskforce will have members drawn from the National Pharmaceutical Pricing Authority, Department of Industry Policy and Promotion, Drugs Controller General of India and pharma industry associations. Secretary of health research, V M Katoch, will chair the committee.The taskforce has to submit its report to the government within three months.
Health Minister Ghulam Nabi Azad had recently met with drug manufacturers in Mumbai and Hyderabad, where pharma industry leaders had requested for a taskforce to prepare a long-term strategy for strengthening the drug sector in the country.
Apart from issues like clinical research, medical devices and R&D in the sector, FDI in the pharma industry has been an area of debate in the recent past. Acquisition of Indian pharmaceutical companies by multinationals could orient them away from the Indian market, thus reducing the domestic availability of drugs produced by them—this was among the many concerns raised by the Ministry of Health and Family Welfare that made the commerce ministry seek a review of the FDI policy in the pharmaceutical sector.
The health ministry advocated doing away with the automatic 100 per cent FDI approval route for the pharmaceutical industry. Foreign investment should be allowed in the pharma sector through the FIPB (Foreign Investment Promotion Board) route, it argued.
The terms of reference of the taskforce would be to evolve a policy, that would look at short, medium and long-term requirements of the pharma sector and to make India a hub for drug discovery, research and development. Also, the committee would evolve strategies to further the interests of Indian pharma industry in the light of issues related to Intellectual Property Rights and recommend strategies to capitalise the opportunity of drugs going off-patent over the next 5 years, a health ministry statement said.
The taskforce has also been mandated to evolve policy measures to assure national drugs security — promoting indigenous production of bulk drugs, preventing take over of Indian pharma industry by MNCs, drug pricing, promotion of generic drugs and recommend measures to assure adequate availability of quality generic drugs at affordable prices.
Measures to tackle the problem of spurious drugs will also be a focus area of the taskforce.
The cases of takeover of Indian pharma companies by MNCs, include Matrix Lab being bought by US-based Mylan Inc; Dabur Pharma by Singapore’s Fresenius; Ranbaxy Laboratories by Japan’s Daiichi Sankyo; Shanta Biotech by France’s Sanofi Aventis; Orchid Chemicals by US-based Hospira; and Piramal Health Care by US-based Abbot Laboratories.
The argument put forward by the ministry is that if Indian pharma giants were taken over by MNCs, they might lose interest in applying for a compulsory licence even if they were eligible, and that might threaten the regime of cheap and effective drugs in the country. Also, in the case of a public emergency, capable drug manufacturers may not be available to come forward to apply for compulsory licence and work at a reasonable cost. It said Indian pharma companies taken over by MNCs had been receiving state grants and tax concessions.