'Drugs & cosmetics bill must consider stakeholder's views'

As the winter session of parliament approaches, AdvaMed and other representatives of the medical device industry have urged the standing committee on health and family welfare to consider their recommendations for the Drugs & Cosmetic (Amendment) Bill 2013 so that the benefits of the measure can result in faster and safer solutions for Indian patients and more investments for the country.

The various organisations and trade bodies, in their submissions, have made detailed recommendations which should be considered when the bill is passed, which could otherwise pose the risk of shortchanging the potential benefits medical device industry can bring to the country an AdvaMed statement said.

India has traditionally had an overwhelming burden of communicable diseases, but non-communicable diseases (NCDs) are fast emerging to be the country's next public health challenge.

The World Health Organization, NCD Country Profiles, 2011 states that more than 53 percent of total deaths every year in India are due to NCDs and by 2020, over 60 million Indians will succumb to them.

'Medical devices play an increasingly critical role in the diagnosis and management of NCDs. As India strives to provide universal health facilities to its citizens, medical technology will become an even more integral part of the country's public health system as these help in the diagnosis and management of complex non-communicable diseases, thereby alleviating pain, restoring health and extending life of the people,' the statement said.

It noted that in its present form, 'there are some significant aspects of the bill that could stifle this enthusiasm even before the potential and utility of medical technology can be fully realized'.

In its submission, AdvaMed has suggested that all the regulations for medical devices be harmonised with international best practices such as the International Organization for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF), 'so that medical device manufacturers achieve the highest standards of safety and efficacy and also become globally competitive'.

'The suggestions also highlight adoption of risk-based approach to ensure timely access to medical technology and revision of provisions related to clinical trials to maintain highest ethical standards,' the statement said.

Abby Pratt, associate vice president (Global Strategy & Analysis) at AdvaMed, said: 'The medical device industry is encouraged by the bill for recognizing medical devices as a separate and critical element of the Indian healthcare delivery system, and believes that the Bill will improve the industry's ability to serve India's growing healthcare needs in a safe, effective and timely manner.'

According to AdvaMed, the industry 'is concerned about the lack of standardisation in line with global best practices like the Global Harmonization Task Force (GHTF) and the IMDRF. Some of the penal provisions as defined in the bill, where even minor violations attract severe penal action often disproportionate to the nature or severity of the crime, are not in line with international practices'.

AdvaMed (Advanced Medical Technology Association) is a trade association of international medical device manufacturers. AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

What is the drugs and cosmetics bill?

The Drugs and Cosmetics (Amendment) Bill 2013 has been introduced in Rajya Sabha with an aim of strengthening the drug regulatory system in India and provides the scope for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics. It seeks to establish a 19-member overarching body to regulate the drugs and cosmetics sector that will be headed by the Secretary, Health and Family Welfare.

Drugs Hall of Shame

Here are some events from the past two years that have shown the country's apex body for drug regulation in bad light:

Pioglitazone ban: The popular anti-diabetic ban was banned with analgin and deanxit, which drew widespread condemnation from the pharmaceutical industry. The drug was banned after one Dr V Mohan, a Chennai-based diabetologist and Chairman of Dr Mohan's Diabetes Specialities Centre, claimed that he found eight cases of bladder cancer linked to pioglitazone use. 'You will agree that as far as human lives are concerned, it does not matter even if only a few people develop bladder cancer and die.' The drug was quickly banned without even consulting the Drug Technical Advisory Board. After much, hue and cry the ban was revoked.

Too many drugs being approved: 'On an average, the DCGI (Drug Controller General of India) is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination,' the panel observed. It also gave examples where the 'opinions of experts' were based simply on 'personal perception'. Some of the recommendations were so blatantly one-sided that it seemed like they were written by pharma companies. (Read: Will the new Drugs and Cosmetics Bill strengthen the drug regulatory system in India?)

Source: IANS

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