A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS, MEDICAL DEVICES, DIAGNOSTICS AND PHARMA INDUSTRY
Our 29th Year of Publication
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Aimed & Regulatory Update

AiMeD Urges Govt To Reduce GST On Certain Medical Devices From 18 to 12%

The Association of Indian Medical Device Industry (AiMeD) has requested various measures including reduction of Goods and Services Tax (GST) on certain medical devices from 18 per cent to 12 per cent among others, in order to avoid the firms slipping their loan repayment even though the announcement of a financial scheme to build healthcare infrastructure is a welcome move.

In a letter to finance minister Nirmala Sitaraman, Rajiv Nath, forum coordinator, AiMeD said that there are supporting policy enablers required so that the loans do not become non performing assets and projects for medical devices to be financially profitable.

“We are delighted with the government announcement of a financial scheme to build healthcare infrastructure which is including diagnostic services & medical devices manufacturing, with a 7.95% interest and for the first time Government of India is being the loan guarantor which will definitely help to partly address the 15% disability factors that have been making India over 70% imports dependent (last years imports at Rs. 45,000 crore),” he said.

Apart from the GST reduction, the Association also referred to its demands including introduction of a predictable nominal tariff structure matching the mobile phone industry to protect investors; monitoring maximum retail price (MRP) of Importers in bills of entry as data to enable capping of two to four times over first point of sale (when GST is charged 1st time).

The other demands include that the government should give price preference based on QCI’s Quality Certification in Public Healthcare Procurement as permissible under GFR 153. It should also seek the customs to enforce restrictions on imports of pre- owned equipment over 3 years and labeling (MRP, Country of Origin and Manufacturers & Importers name and address).

No export restrictions & phasing out of various duty exemption notifications on medical devices as announced by the finance minister in this year’s Budget.

The Government has announced Loan Guarantee Scheme for Covid-19 Affected Sectors (LGSCAS) to provide guarantee to scheduled commercial banks for loans given for new projects, both greenfield and brownfield, related to healthcare infrastructure. The Scheme was approved by the Union Cabinet on June 30, 2021 and the loans are made available at a cheaper interest rate of 7.95 per cent.

LGSCAS provides a guarantee of 50 percent for brownfield projects and 75 per cent to greenfield projects for loans sanctioned up to Rs.100 crore, set up at urban or rural locations other than 8 Metropolitan Tier 1 cities (Class X cities). For aspirational districts, the guarantee cover for both brownfield expansion and greenfield projects is 75%. The Scheme is applicable to all eligible loans sanctioned up to March 31, 2022, or till an amount of Rs. 50,000 crore is sanctioned, whichever is earlier.

The finance minister, in a webinar on building healthcare infrastructure for new India, emphasised that the most important support to healthcare infrastructure is to ramp up capacities, technology, better facilities and above all ramp up trained manpower for optimally utilizing the healthcare infrastructure.

“With such team work & enabling policies we can become globally competitive and in 5 years we can increase our exports from Rs. 20,000 crore to over Rs. 50,000 crore, increase investment in this sector to over Rs. 50,000 crore and stall and reverse our ever increasing import bill which surpassed Rs. 45,000 crore last year,” added Rajiv Nath.

http://pharmabiz.com/NewsDetails.aspx?aid=142318&sid=1


EXCLUSIVE I Modi Govt Sets Up Panel to Frame New Laws for Medicines, Cosmetics, Medical Devices

The Modi govt has asked the newly formed panel to submit the draft of the new Act by November 30. Industry experts say it will take at least one year to notify the new law.

The Narendra Modi government has formed a panel to frame new laws for medicines, cosmetics and medical devices, News18.com has learnt. The newly formed eight-member panel, headed by the drug controller general of India, VG Somani, will submit the draft document by November 30.

According to India’s apex regulatory body, Central Drugs Standard Control Organisation (CDSCO), the Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Recently, it was amended to add medical devices.

According to the internal order, accessed by News18.com, “The government has decided to constitute a committee for framing/preparation of New Drugs, Cosmetics and Medical Devices Bill so that New Drugs, Cosmetics and Medical Devices Act can be framed.”

The other members of the panel include Rajiv Wadhawan (director, Ministry of Health and Family Welfare), Dr Eswara Reddy (joint drug controller), AK Pradhan (joint drug controller), IAS officer NL Meena followed by drug controllers of Haryana, Gujarat and Maharashtra.

“The committee shall undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft document for a de-novo Drugs, Cosmetics and Medical Devices bill,” said the order dated 27 August. The order is titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’.

New Act is the need of an hour: Industry.

In 2020, the Ministry of Health and Family Welfare had brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulation. According to the pharmaceutical industry experts, a new Act is the need of the hour. “The Act is completely obsolete as it was formed in 1940. Since 1940, it has undergone multiple amendments. It has now become very confusing and unclear for the industry,” said an official representing a lobby group of top pharmaceutical companies.

“If the government has started the process now, it will take at least one year to notify the new law as the draft will first go to Lok Sabha, Rajya Sabha and then to the President.”

Another official representing a pharmaceutical firm said, “The act doesn’t talk about anything latest. For instance: It does not allow online sales of medicines as it dates back to the pre-Independence era. We need the latest act immediately.”

However, industry experts pointed out that the panel must contain officers from several other fields. “This is a huge conflict of interest to create such a committee without representation from other stakeholders like manufacturers, doctors, academia, scientists and consumer or patient bodies,” said Rajiv Nath, forum coordinator, Association of Indian Medical Devices Industry.

https://www.news18.com/news/india/exclusive-modi-govt-setsup-panel-to-frame-new-laws-for-medicines-cosmetics-medicaldevices-4178255.html

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