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Doctors and office-bearers of Central Procurement Department (CPD) of the Municipal Corporation of Greater Mumbai (MCGM) are favouring foreign companies to get the contract of manufacturing medical devices by making USFDA and European CE mandatory. This has been done at a time when ISO 13485 has been mandated in India under the Medical Device Rules for Indian medical device manufacturers, All Food and Drug License Holders Foundation (AFDLHF) has revealed.
Abhay Pandey, president, AFDLHF further stated, “These kind of shady deals will be a big setback to Narendra Modi’s Make in India' campaign. The CPD of MCGM mandating USFDA and European CE as prequalification criteria in MCGM Schedule -4. (Part-1&2) makes it evident that foreign currency is most likely involved in this deal in connivance with MCGM officials, doctors and MCGM CPD officers.”
Prime Minister Narendra Modi launched the 'Make in India' campaign to facilitate investment, foster innovation, enhance skill development, protect intellectual property and build best in class manufacturing infrastructure.
He further said that CPD also violates the Drugs Controller General of India (DCGI) regulation of ISO 13485 which is mandated to the manufacturer of medical devices in India. Indian manufacturers who currently with the help of the Central Government have started massive exports of angiographic, urological catheters and sheaths and many other devices in various countries of the world. It is unethical and illegal that BMC refuses them active participation in the said tender.
“The said tender was published on January 11, 2023 and prebid meeting was kept on January 18, 2023, wherein 14 and 15 January were public holidays. Receipt of pre bid requests were asked to be submitted on email on or before January 16, 2023 at 11 AM. This timetable itself makes it amply clear that there was some vested interest of CPD,” AFDLHF members said.
They have revealed that around 80%-90% products pre qualifying criteria is such that Indian medical devices manufacturers will not be able to qualify. With this, they are not only deprived of their rights as Start Up or Make in India but also their integrity towards quality manufacturing was questioned. This is gross violation of DCGI guidelines and also violation of Ministry of Health and Family Welfare office Memorandum dated November 5, 2019, which clearly states that restrictive clauses such as USFDA and European CE are discriminatory and are not tenable.
“This schedule now attracts the attention of the Enforcement Directorate (ED) as shady foreign currency transactions are involved,” according to sources. MCGM officials have, however, declined to comment on the same.
This comes close on the heels of Covid centre contracts scam in which ED is probing Mumbai civic body in connection with alleged irregularities in awarding of contracts for Covid care centres in which the firm named Lifeline Hospital Management Services involved had submitted forged documents to the civic body and obtained a contract of a Jumbo Covid Centre in Mumbai.
Last August, BJP leader Kirit Somaiya had tweeted, “Rs 100 crore Covid centre scam: Police registered my FIR (under IPC Section 756) against Sanjay Raut, partner of Sujeet Patker, and Lifeline Hospital Management Services under IPC sections 420, 406, 304A and 34. Worli, Mulund, Mahalaxmi Racecourse, Mulund, Pune Shivaji Nagar Centres’ contracts obtained by fraud.”
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