Medical devices industry needs separate set of rules

AdvaMed, an association of medical device manufacturers, stressed that in the light of many regulatory hurdles the industry is facing in India, it is high time for the government to frame a specific set of acts and rules for the medical devices industry. The association welcomed the government’s effort to create a distinction between medical devices and drugs through a separate chapter in the Drugs & Cosmetics (Amendment) Bill, and its commitment to tackling non- communicable diseases.

AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”

Aushadi Stores - Success in India

To make a people oriented programme like Jan Aushadi a success in a country like India, support of state governments, medical practitioners and other stakeholders is crucial. One of the main reasons for the slow progress of Jan Aushadi is the lack of this support from the state governments and medical profession. Perhaps, Gujarat is one state that has given some support by launching the Jan Aushadhi stores in a few government hospitals.

The state government is also motivating doctors working in the government hospitals to prescribe unbranded generic medicines to the patients. Most of the other state governments have not extended such support to this programme as yet. However, state governments like Andhra and Kerala have launched their own subsidised medicine programme by setting up  government owned chains providing both branded and unbranded drugs at 20 to 25 per cent lower than the market prices. These regional initiatives,no doubt, have their own merits but what is required is to make the national programme a success throughout the country so that generic drugs will be available at uniformly lower prices to all. Regular procurement of quality drugs at low prices is an important task for the success of this scheme.


The department’s decision to source generic drugs from private sector manufacturers is thus a step in right direction. But the move to restrict such purchases to only from firms having an average annual turnover of Rs. 10 crore in the last three years is not fair. This will keep several small players having reputation of makers of quality drugs out of the programme. The procurement should not be too restrictive as that may discourage competition and lead to high procurement prices.