Govt approves scheme to boost domestic manufacturing of medical devices

Source: Business Standard, Mar 21, 2020

New Delhi: The government on Saturday approved a production-linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, with financial implications of Rs 3,420 crore.

The Union Cabinet headed by Prime Minister Narendra Modi also approved another promotion of medical device parks scheme worth Rs 400 crore for financing common infrastructure facilities in four medical device parks, an official statement said.

The expenditure to be incurred for the said schemes will be for the next five years i.e. from 2020-21 to 2024-25, it added.

“The Union cabinet has approved a scheme on promotion of medical device parks for financing common infrastructure facilities in four medical device parks with financial implications of Rs 400 crore, and approved the Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of medical devices with financial implications of Rs 3,420 crore,” it said.

Under the sub-scheme for promotion of medical device parks, common infrastructure facilities would be created in four medical device parks, which is expected to reduce manufacturing cost of medical devices in the country.

“The PLI scheme for promoting domestic manufacturing of medical devices would boost domestic manufacturing and attract large investments in the medical device sector, particularly in the identified target segments. It will lead to expected incremental production of Rs 68,437 crore over a period of five years,” the statement said.

The medical device sector suffers from a cost of manufacturing disability of around 12 per cent to 15 per cent, vis-a-vis competing economies, among other factors, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low focus on research and development activities (R&D) and skill development, etc.

There is, thus, a need for a mechanism to compensate for the manufacturing disability, it said. It further said that the schemes have potential to generate

an additional employment of 33,750 jobs over a period of five years and reduce import of target segments of medical devices.

Govt approves Rs 13K-crore package to boost bulk drugs manufacture

Source: Business Standard, Mar 21, 2020

Mumbai: The Union government on Saturday approved a package comprising four schemes with a total outlay of Rs 13,760 crore to boost the domestic production of bulk drugs and medical devices and exports.

The Union Cabinet chaired by Prime Minister Narendra Modi approved outlay of Rs 9,940 crore and Rs 3,820 crore for bulk drugs and medical devices, respectively, Minister of State for Chemicals and Fertilizers Mansukh Mandaviya told reporters.

The Cabinet also approved a sum of Rs 3,000 crore for the next five years for a scheme to promote bulk drug parks and for financing common infrastructure facilities at three such parks, he added.

A sum of Rs 6,940 crore has been approved for the Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting material (KSM), drug Intermediates and active pharmaceutical ingredients (APIs), Mandaviya said. The PLI scheme will lead to expected incremental sales of Rs 46,400 crore and significant additional employment generation over eight years, he added.

The plan is to develop three mega bulk drug parks in partnership with states. The Centre will provide grants-in-aid to states with a maximum limit of Rs 1,000 crore per park.

Financial incentive will be given to eligible manufacturers of 53 identified critical bulk drugs on incremental sales over the base year (2019-20) for a period of six years. Of these drugs, 26 are fermentation-based bulk drugs and 27 are chemical synthesis-based bulk drugs. The rate of incentive will be 20 per cent (of incremental sales value) for fermentation-based bulk drugs and 10 per cent for chemical synthesis-based ones.

Meanwhile, the scheme for promotion of medical device parks will provide a maximum grant-in-aid of Rs 100 crore per park to states. It will have financial implications of Rs 400 crore, Mandaviya said.

“The PLI scheme for promoting domestic manufacturing of medical devices with financial implications of Rs 3,420 crore,” he added. The expenditure to be incurred for the schemes on promotion of medical devices will be for the next five years.

Under the sub-scheme for promotion of medical device parks, common infrastructure facilities would be created at four parks, which is expected to reduce manufacturing costs.

“It will lead to expected incremental production of Rs 68,437 crore over five years,” he said.

He added the schemes have potential to generate an additional employment of 33,750 jobs over five years and reduce import of target segments of medical devices.

However, even as the government gears up to reduce import dependence for pharmaceutical raw material and medical devices, the sector said the immediate focus should be on utilising existing capacities.

Yogin Majmudar, a bulk drug unit owner and head of the bulk drug committee of the Indian Drug Manufacturers’ Association (IDMA), said in the scheme, the support to be extended to brownfield units was not clear. “There can only be an immediate increase in production from these units. Parks are a longer-term solution with a horizon of a minimum of three years,” he said.

Around 40 per cent of installed capacity is estimated to be lying idle, he said.

Majmudar added that environment regulations needed to be tweaked to get faster approvals. The focus should have been on effluent quality and quantity and not on the product portfolio of an API unit. In the announcement there was no mention of that, a major hindrance to quick production, he said. Rajiv Nath, forum coordinator of Association of Indian Manufacturers of Medical Devices, said, “We are more than hopeful that these schemes announced would help boost local manufacturing and will accelerate medical devices manufacturing as a ‘Make in India’ enabler, make quality healthcare accessible and affordable for common masses, enable placing India among the top five medical devices manufacturing hubs worldwide and help end the 80-90 per cent import dependence forced upon us and an ever increasing import bill of over Rs 38,837 crore”.

Medical devices to be treated as drugs from the next financial year

Source: Business Standard, Feb 12, 2019

Mumbai: Come April 1, all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940, the ministry of health and family welfare said in a notification on Tuesday.

At present, only 23 medical devices have been classified as drugs. Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control.

The health ministry said the decision was taken after consultation with the Drugs Technical Advisory Board (DTAB), the apex decision making body on technical matters related to drugs. Read the rest of this entry »

Govt issues new guidelines for foreigners seeking organ transplant in India

Source: Business Standard, Nov 22, 2018

New Delhi: The Health Ministry has made it mandatory for foreign nationals seeking organ transplant in India to be registered in the waiting list of hospitals following reports claiming they were being given preferential treatment by some private institutions.

The registered transplant centre has to intimate the Regional Organ and Tissue Transplant Organisations (ROTTOs) and the list of foreign nationals seeking organ donation in India has to be shared with the NOTTO (National Organ and Tissue Transplant Organisation) in advance, officials said here.

Also, an organ can be allotted to a foreign national only if there is no Indian recipient available to receive the donated organ at that time, said Dr Vasanthi Ramesh, Director of NOTTO.

Among the patients from abroad, NRIs and persons of Indian origin will be given preference. Read the rest of this entry »

India flags off first ever healthcare facility census

Source: The Hindu Business Line, Jun 19, 2018

New Delhi: In a first-of-its kind endeavour, India is conducting a census of healthcare establishments in the country. Counting health facilities, including public and private hospitals, diagnostic labs, clinics, pharmacies and nursing homes will be crucial to the implementation of Ayushman Bharat — the cashless insurance scheme to be rolled out for ten crore families later this year.

Under the Collection of Statistics Act, 2008, estimated data of over 20 lakh facilities will be enumerated on over 1400 variables in the National Health Resource Repository (NHRR).

Read the rest of this entry »

8 states, 4 UTs sign MoUs with health ministry to implement Ayushman Bharat

Source: Business Standard, Jun 09, 2018

New Delhi: Eight states and four Union Terrorities have signed MoUs with the Union Health Ministry to implement the government’s ambitious national health protection mission, which aims to provide a cover of Rs 500,000 per family annually to 100 million vulnerable families, an official said today.

Four states – Delhi, Odisha, Punjab and West Bengal – have not yet given any positive response towards adopting the programme, the health ministry official said.

Read the rest of this entry »

‘Healthcare sector may touch ₹8.6-lakh cr by FY22’

Source: The Hindu Business Line, May 13, 2018

Mumbai: The healthcare industry is expected to grow annually at 16-17 per cent to reach ₹8.6 lakh crore by FY22 on the back of the Centre’s Ayushman Bharat scheme which, if implemented successfully, can go a long way in meeting the severe shortage of healthcare infrastructure, says a brokerage report.

The significant interest in acquiring Fortis Healthcare signifies the attractiveness of the domestic healthcare industry, says the report.“We believe the key reasons for this interest is the shortage of healthcare infrastructure, including bed capacity, medical practitioners, etc., and the government’s mega plan of expanding healthcare reach across the country through the Ayushman Bharat scheme,” ICICI Securities said in a weekend note.

Hospitals are expected to grow at 16-17 per cent CAGR to reach ₹8.6 lakh crore by FY22 from ₹4 lakh crore in FY17.

Interestingly, the present strength of doctors in the country can handle about double the current beds considering the ratio of beds per doctor in other emerging nations as also the global average.

“We believe the Ayushman Bharat scheme can provide significant growth opportunity for hospitals, though its successful implementation has to be seen,” it noted.

 Infrastructure shortage

Looking at the infrastructure shortage in the sector as a growth opportunity, the report notes the country has just 0.7 beds per 1,000 people compared to the global average of 2.7 and the WHO recommendation of 3.5 beds.

This is why hospitals are in expansion mode.

In terms of manpower, the country has just 0.7 physicians and 1.7 nurses per 1,000 people compared to the global average of 1.4 physicians and 2.9 nurses respectively.

Therefore, there is significant untapped opportunities.

The ambitious Ayushman Bharat seeks to provide healthcare coverage of ₹5 lakh each for 100 million families. Implementation of such a large plan can provide huge growth potential for healthcare companies, the report said.The industry also has been facing several challenges on pricing and margins. Considering the government focus on providing low-cost healthcare services to the poor, these challenges are expected to continue.

To overcome pricing challenges, hospitals should focus on diversified speciality mix rather than single therapeutic area.