At a time when multinational companies are planning to withdraw their medical devices such as coronary stents from the Indian market following the pricing cap, the Prime Minister’s Office (PMO) has asked the Union health ministry to chalk out an action plan for “certification of medical and advance diagnostic devices” to boost their domestic production. In this regard, the Department of Pharmaceuticals (DoP) on October 5 requested the ministry to convene a meeting, if necessary, for finalising the plan.
Currently, there is no mandatory quality certification system for thousands of medical devices sold in India. However, companies that are manufacturing and selling 23 medical devices — which have been specifically classified as ‘drugs’ under Drugs and Cosmetics Act, 1940 — need to get a ‘drug’ manufacturing licence. “In absence of licensing by a regulator or a certification, how does a start-up with unknown brand convince a government hospital like AIIMS (All India Institute of Medical Science) to use its product, even for free even if made by IIT (Indian Institute of Technology) for evaluation?” Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AIMED), told The Indian Express. AIMED is the organisation of Indian medical device companies.
Nripendra Misra, principal secretary to the Prime Minister, chaired a meeting on the ‘issues related to science and technology in the country’ on July 15 this year. At this meeting, it was decided that the health ministry should be asked to “look into issues related to certification of medical devices and advance diagnostic devices and make them in India and its action plan”. On September 5, a PMO official wrote a letter to the health ministry asking for the aforementioned action plan.
On September 8, the health ministry wrote an e-mail to G N Singh, Drug Controller General of India (DCGI), wherein it mentioned that the PMO letter was received three days ago and further stated: “It may be requested to look into issues related to certification of medical and advance diagnostic devices to make them in India requires a holistic consideration and chalk out an action plan (with the timelines) for making these devices in India.” The DCGI works under the Union health ministry.
The DCGI replied to the e-mail on September 8 itself: “In order to promote manufacturing of medical devices and in vitro diagnostics in the country and for ease of doing business, provisions are made in the said Rules for timely audit and approvals for manufacturing licences. The Medical Devices Rules, 2017, has been harmonised based on international practice where provisions of third-party audit have been incorporated. Nevertheless, for certifications, if required, a consultation with QCI (Quality Council of India), BIS (Bureau of Indian Standards) and IPC (Indian Pharmacopoeia Commission) Ghaziabad will be taken.”
In vitro diagnostics (IVD) are tests that can detect diseases, conditions, or infections. Some IVD tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. In his reply, the DCGI added: “Promotion and encouragement under the Make in India programme, for medical devices and in vitro diagnostics, does not fall under the MoHFW (Ministry of Health and Family Welfare). For that, DIPP (Department of Industrial Policy & Promotion) or concerned ministry may be consulted.”
The Union health ministry was not satisfied with the reply sent by the DCGI. After reading the DCGI’s reply, R K Vats, additional secretary, MoHFW, noted in the file: “We need to provide an action plan for certification. We cannot say that we will consult QCI, BIS, etc, for certification ‘if required’. Please resubmit within September 28.” The Union health ministry wrote an e-mail on September 26, asking the DCGI to send the action plan for certification by the end of next day. As the ministry received no response, it sent two reminders — dated September 28 and October 12 — to the DCGI to submit the action plan.
Meanwhile, on October 5, the DoP, which works under the Ministry of Chemicals and Fertilizers, wrote to the Union health ministry that “if necessary, a meeting in this regard could be convened on a mutually convenient date and time to discuss and finalise the action plan”. The DCGI did not respond to the queries of The Indian Express.
In 2016, to fill the regulatory vacuum in quality certification space for medical devices in the country, the AIMED in collaboration with the QCI and the National Accreditation Board for Certification Bodies (NABCB) rolled out a voluntary quality certification scheme for medical devices called Indian Certification for Medical Devices (ICMED). “Over nine manufacturers have achieved this certification and 24 additionally are expected to get this shortly. Over 100 manufacturers are expected to get this in 2018,” said Nath. He added: “Prior to ICMED, there was no India-specific official quality assurance system to address patient safety needs due to which Indian medical device manufacturers encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits… Indian manufacturers were forced to seek CE (European) certification or USFDA certification, which costs many lakhs of rupees for low-risk devices, to gain some level of credibility to convince public and private healthcare professionals to buy their devices. USFDA certification is prohibitively expensive and cost of getting a pre-market approval is currently Rs 1.5 crore which will be over Rs 2 crore with effect from January 1, 2018.”
On February 13, the National Pharmaceutical Pricing Authority (NPPA) capped the prices of coronary stents. The ceiling price of bare metal stents (BMS) has been fixed at Rs 7,400 per piece and that of drug eluting stents (DES) and biodegradable stents has been fixed at Rs 30,180 apiece. The NPPA did not put a separate price cap for biodegradable stents as requested by multinational companies such as India Medtronic, Abbott Healthcare and Boston Scientific India. Consequently, companies such as Boston Scientific India and Abbott Healthcare have requested the NPPA to let them withdraw their latest-generation stents, which include biodegradable stents, from the Indian market.
Just like stents, the central government imposed a price cap on knee implants in August this year. Last month, American multinational companies — through their association named Advanced Medical Technology Association (AdvaMed) — filed a petition with the US Trade Representative (USTR) requesting that India’s benefits under the Generalised System of Preferences (GSP) be suspended or withdrawn “in light of India’s failure to provide equitable and reasonable access to its market for medical devices”. GSP is a preferential tariff system extended by developed countries to developing countries.
On November 9, the NPPA stated that it is planning to ‘revisit’ the stent price cap in the time period of January to February next year. “The NPPA has received some representations with regard to pricing and other related issues. All the domestic stent manufacturers and all importers are advised to submit any representation/suggestion on this issue positively by December 31, 2017,” the NPPA stated.