Govt Plans To Set Up Body To Regulate Medical Devices Sector

New Delhi, 26 Sept 2019:

The government is planning to set up a Medical Devices Authority (MDA) for the entire spectrum in the medical devices sector — gauges, weighing machines, orthopaedic implants or whatever.

It will, however, not have powers on pricing. That will continue to be vested with National Pharmaceutical Pricing Authority (NPPA), senior officials said.

The proposed body will be separate from the Central Drugs Control Standard Organisation (CDSCO), which will continue to be the regulator for drugs.

The Bureau of Indian Standards (BIS) will still frame guidelines but these would be regulated by MDA. The arrangement would be on the lines of food items, where BIS designs the standards but these are enforced by the Food Safety and Standards Authority of India. For, BIS itself doesn’t have implementing powers, said a senior government official who is working on the proposed MDA.

He said the body would comprise representatives from the industry, policy makers and active medical practitioners. It will get its role, powers and objectives from a Medical Devices Act, whose provisions are being framed.

“Government agencies, along with BIS, are formulating the Act. The draft has been made and BIS has already made 1,325 standards for more than 1,000 product lines,” added the official. NITI Aayog is also involved in the process.

The plan is to stop using norms borrowed from the American regulator, the Food and Drugs Administration (FDA), for procurement by state and central governments once MDA is put in place.

Currently, medical devices are the responsibility of the central drug regulator but are treated akin to.

As many as 22 medical devices have been categorised as drugs and are the only ones that are regulated. The rest are sold in the market without any particular standards governing these. Imported medical devices are given approval in India if they have US FDA approval or from the European Union.

Medical device makers say they are not very comfortable with the idea of BIS framing a law. They feel CDSCO should be doing it.

Meanwhile, the government is also working on rules for rationalising the trade margins for medical devices that have been categorised as drugs. This includes intraocular lenses. The government has already capped the prices of cardiac stents and orthopaedic knee implants. NITI Aayog and the department of pharmaceuticals are together working on a formula to cap the prices of other medical devices that are considered drugs.

Devices not characterised as drugs cannot be brought under price caps by the NPPA, using the Drug Price Control Order.

Remedy for sector

The proposed body will be separate from the Central Drugs Control Standard Organisation

It would have representativesfrom the industry, policy makersand active medical practitioners

The plan is to stop using norms borrowed from the American regulator, the Food and Drugs Administration

The government is also working on rules for rationalising the trade margins for medical devices that have been categorised as drugs. Business Standard

FSSAI Advisory On Labelling Defects Of Health Supplements And Nutraceutical Products (26-09-2019)

New Delhi, 24 Sept 2019: Through an advisory dated 18 September 2019, the FSSAI has drawn attention to certain labelling defects on packaging of Health Supplements and Nutraceutical products. The advisory has been sent so that both food manufacturers as well as FSSAI officials can keep a check to ensure that the labelling is accurate.

The FSSAI has received reports that some food products including Nutraceuticals and Health Supplements products that have gelatine/gelatin shells or which contain ingredients of animal origin are depicting a green dot on their labels. The green dot logo is a mark that declares these products as vegetarian products. Therefore, marking such products as vegetarian is in contravention of the Food Safety and Standards (Packaging and Labelling) Regulations 2011, which mandates application of the veg/no-veg logo on pre-packed food products according to their contents. The above-mentioned labelling shall therefore, be considered as misbranding and labelling defects.

It may be noted that all the food products falling under the category of Nutraceutical/Health Supplement shall have to comply with the Food Safety and Standards (Health Supplements, Nutraceutical, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 as well as the Food Safety and Standards (Packaging and Labelling) Regulation, 2011, failing which they will attract penal provisions under FSS Act, 2006.

In view of the above the FSSAI has requested Commissioners of Food Safety of all States/ UTs, FSSAI Authorised Officers and the Central Licensing Authority to initiate enforcement drives so as to keep a check on the sale of such food products in all states and which are in contravention with FSS (Packaging and Labelling) Regulation, 2011. They have also been advised to initiate appropriate action against the defaulting Food Business Operators as per the provisions laid down under FSS Act,2006, and Rules and Regulations made thereunder. Food Safety Helpline