As the deadline for responding to the draft norms for public procurement of medical devices is drawing nearer, domestic manufacturers have decided to approach the government to scrap certain ‘discriminatory’ clauses in the guidelines to protect the interests of the Indian industry.

The draft norms issued on February 20 stated that in the case of medical equipment where Indian standards (BIS) were not available, the indenting organisation would be free to insist on US FDA, European CE or other certification. According to the Association of Indian Manufacturers of Medical Devices (AIMeD), the order should have allowed manufacturers to have ISO, ICMED, CE or US FDA approval and not left it to the buyers to insist on any one of these. If a buyer chooses US FDA in the absence of BIS, Indian bidder would remain disqualified if it doesn’t have the American certification.

“This is disappointing and unacceptable. We will soon meet joint secretary in charge of procurement at the ministry of health to raise this issue. We are also compiling comments from our members. A formal letter is being drafted, which will be sent to the ministry and the DoP,” AIMeD Forum Coordinator Rajiv Nath told Pharmabiz.
The time limit to submit a response ends on April 5.

The Indian manufacturers’ demand got a new push last week when the Parliamentary Standing Committee on Health flayed the practice of insisting on US FDA approval for medical devices procured by the government pointing out that there was hardly any country other than the US that made it mandatory. Slamming the clause in the draft guidelines, the panel observed that US FDA was for control and supervision of food and drugs including medical devices in the US.

According to Nath, Indian manufacturers are facing discrimination in the US and China. Both the nations are using non-tariff barriers to stop Indian companies from bidding for their government tenders. The draft PMA policy in its present form does not provide preferential pricing to Indian companies, no incentives on improving quality and no redressal provisions against use of mandatory third country regulatory approval clauses.

In fact, Indian medical device makers have been pointing the finger at public institutions for structuring tenders that discriminate against domestic companies in favour of foreign firms. According to Public Procurement (Preference to Make in India) Order, 2017, “procuring entities shall endeavour to see that eligibility conditions, including on matters like turnover, production capability and financial strength, do not result in unreasonable exclusion of local suppliers who would otherwise be eligible, beyond what is essential for ensuring quality or creditworthiness of the supplier.” But this rule is frequently flouted, say industry observers.  

The manufacturers also try to pick specific tenders to bring this issue to the attention of authorities and push their cause forward. “Northern Railway tenders for supply of intraocular lens (IOL) seeks US FDA approval when India is the largest maker of IOL. Another railway tender for orthopaedic implants also seeks US FDA approval when there are CDSCO-approved Indian manufacturers,” AIMeD stated on its official Twitter handle on April 2.

Getting US FDA approval is an uphill and expensive task for most local manufacturers. Moreover Indian companies are prohibited from participating in public procurement tenders in the US because India is not a signatory to the US Trade Agreements Act. By making these conditions mandatory here, the government effectively debar Indian manufacturers from even taking part in the bidding process, an industry representative pointed out.