Govt removes restrictions on export of PPE, allows export of N95 masks with restrictions

Source: The Economic Times, Aug 25, 2020

Mumbai: Indian manufacturers will now be able to freely export personal protective equipment (PPE) as the government on Tuesday removed restrictions on the export of medical coveralls.

The export of 5 million N95 masks and 2 million medical goggles a month has also been allowed, according to a notification from the Directorate General of Foreign Trade. The export of nitrile gloves continues to be prohibited.

Masks other than the N95/FFP2 category and face shields can also be freely exported.

The government had put restrictions on the export of medical equipment like PPE, masks, and gloves to prevent a shortage of these items in the country during the coronavirus pandemic. However, as local production capacity ramped up and the domestic demand was adequately served, manufacturers lobbied the Centre to allow the export of these items to generate additional revenue to counter the decline in the apparel business.

China’s Fosun pulls out of $300 million healthcare deals amid negative sentiment

Source: The Economic Times, Jul 15, 2020

NEW DELHI: Chinese conglomerate Fosun has pulled out of discussions for investment in two healthcare companies, a Mumbai-headquartered dialysis services chain and a Bengaluru-based hospital, after India tightened regulations for Chinese investments, according to executives aware of the matter.

According to sources, both deals were at an advanced stage, and Fosun had formally proposed terms for acquiring a stake in the companies, one of which is Apex Kidneycare. The name of the Bengaluru-based hospital could not be immediately ascertained.

The two planned investments were cumulatively worth over $300 million, according to these sources.

Though the immediate trigger for pulling out of the proposed investments seems to be recent regulatory scrutiny by Indian authorities, sources said Fosun is planning to scale down its investment activity in India amidst heightened anti-China sentiment.

The Shanghai-headquartered firm now intends to focus fresh investment activity on Southeast Asia and its objective in India will be to manage existing portfolio companies, according to sources privy to internal deliberations at the company.

The sources insisted that the company would go slow on fresh investments. However, a company spokesperson said it planned to continue to “cultivate” the Indian market.

“Fosun’s goal this year is focusing on core industries and strengthening regional operations, and achieving industry-leading positions in all of our core businesses,” the spokesperson said in an emailed response to ET’s queries.

“From a regional perspective, Fosun will continue to cultivate our existing regional markets as well as the emerging markets such as India.”

Apex Kidneycare had not responded to ET’s queries until press time.

Fosun also has a portfolio of venture capital investments under a firm called Fosun RZ Capital.

Amongst its major VC bets in India are investments in logistics unicorn Delhivery and travel booking site makemytrip.

Incidentally, Fosun announced a plan to list Gland Pharma on the Indian bourses last weekend. It had purchased the Hyderabad-based company from private equity firm KKR for $1.1 billion four years ago.

In a filing to the Hong Kong Stock Exchange, the company said it had filed papers with the Indian stock market regulator Sebi for an initial public offering (IPO).

A source close to the company said that the planned IPO would help it “take some money off the table”.

Founded by first generation entrepreneur Guo Guangchang two decades ago, Fosun quickly rose to become the largest private sector company in China before ceding that spot to companies such as Huawei.

Guangchang, who is often termed China’s Warren Buffett, made headlines when he reportedly went ‘missing’ in 2015. He was later found to be detained by police and the company claimed he was assisting an anti-corruption investigation.

The Chinese billionaire has been a member of the Chinese People’s Political Consultative Conference, a sort of upper house of parliament in that country.

Fosun owns prized assets globally. Amongst these are holiday resorts company Club Med, a prime commercial building in downtownManhattan that it purchased from JP Morgan and English premier league football club Wolverhampton Wanderers.

In India, its venture capital arm has been more active with investments in companies such as payments platform DOT Pay, pregnancy appMylo, logistics firm Letstransport and travel search venture Ixigo.

The company’s senior most private equity executive in India, Nav Khosla, recently quit to join Quadria Capital to look at Southeast Asian investments for that firm.

India simplifies clinical trial rules for Covid-19 vaccine manufacturing

Source: Business Standard, Jun 04, 2020

Mumbai: The health ministry has allowed some relaxations to the Drugs and Cosmetics Act, 1940, and the subsequent rules. This has been done to make “suitable vaccines” available to meet emergency requirements arising due to the pandemic.

Simpler rules would help Indian players to get a vaccine to the market faster.

Earlier, if a company intended to manufacture and stock vaccine for Covid-19, which is under clinical trial, it had to follow a complex process for marketing authorisation (for sale or distribution). Several applications were to be made for conducting clinical trials. Upon completion of the trials, the firm had to again follow a series of application processes. A prior permission was also required from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019, to manufacture the vaccine.

Now, the health ministry has said some of the rules shall be “deferred in public interest” to meet the situation. “We are in talks with vaccine makers here. So far, it looks like some of the global candidates, like the Oxford one, may be available sooner than the others. There are some key Indian candidates, too. The government will take an inter-departmental approach to ensure that the right vaccine candidate is available for Indians at the earliest,” said a government official.

Already, Indian vaccine majors are moving rapidly towards developing the right vaccine that would offer protection against Covid-19.

Hyderabad-based Bharat Biotech is developing a vaccine with the Indian Council of Medical Research (ICMR).

The researchers have recently indicated that the next month is a crucial stage in this development. Pune-based Serum Institute is in discussions with AstraZeneca that has booked millions of doses for Oxford’s frontrunner Covid-19 vaccine candidate. Serum is trying to sign a deal with the British drug major and if everything goes well, it plans to make 100 million doses of the vaccine in India.

Medical device industry to get over ₹3,000 crore boost

Source: The Hindu Business Line, May 31, 2020

New Delhi: Domestic medical devices industry is set to receive a booster dose as central government lays out plan to incentivise Indian players with at least ₹3,420 crore, over a period of five years. This incentive would be provided if they were to invest in their set-ups to produce key medical devices.

Officials in Department of Pharmaceuticals (DoP) said that the domestic manufacturing for cancer care and radiotherapy medical devices, radiology and imaging medical devices, anaesthetics and cardio-respiratory medical devices including catheters of this category meant for the heart and, renal care medical devices meant for kidneys, all implants including implantable electronic devices like cochlear implants meant for those with hearing impairment and pacemakers for the heart, will be given priority.

DoP ina notification proposed to pay a production linked incentive (PLI) of five per cent on incremental sales (over base year of 2019-20) of goods manufactured in India covered under target segments to eligible companies for a period of five years (2020-21 to 2025-26).

The notification states that on incremental investment of ₹180 crore over three years, with at least cumulative minimum ₹60 crore investment in first year. And then ₹120 crore in second year and eventual incremental sales of manufactured goods, say for instance, which are ₹120 crore in first year, reaching to ₹240 crore in the second, ₹360 crore in third year, ₹460 crore in the fourth year, reaching up to ₹560 crores in five years. DoP has proposed to dole out through reimbursements, an incentive of five per cent each year on that year’s incremental sales to the medical device companies.

According to data compiled by DoP, India’s medical device market stood at ₹50,026 crore for 2018-19 and is skewed in the favour imports which were to the tune of ₹43,365 crore, while exports were ₹16,300 crore. While both exports and imports grew at 25. 2 and 23.8 per cent as compared to 2017-19, and it is expected to touch ₹86,840 crore in 2021-22, officials said that there is a lack of level playing field in India versus the competing economies.

“India’s share is 1.6 per cent in global market, and it is among the top 20 medical devices market in Asia, and comes after Japan, China, South Korea. Still, Indian industry depends on imports up to an extent of 86 per cent and PLI scheme for medical devices is a financial incentive to boost domestic manufacturing and attract large investments in medical devices sector,” said a DoP official.

“Lack of adequate infrastructure, domestic supply chains, logistics, high cost of finance, limited availability of quality power supply, limited design capabilities, low focus on R&D, and skill development are the main roadblocks,” the official explained. DOP would appoint a nodal agency to act as a Project Management Agency for appraising of applications and verification of eligibility of the company for support under the scheme. An empowered committee consisting of Secretaries of Pharmaceuticals, Commerce, DPIIT, Health and Director General of Foreign Trade will then consider the applications for approval and conduct periodic reviews of eligible companies.

World Bank offers $1bn for proposed India project

Source: The Economic Times, Apr 01, 2020

Mumbai: The World Bank has offered $1 billion to the Indian government for a proposed India Covid-19 emergency response and health systems preparedness project. This four-year project aims to develop the preparedness of India’s health care systems in the time of the pandemic.

The idea of the project will be to respond and mitigate the Covid-19 threat and strengthen national systems for public health preparedness in India, as per the project document.

The World Bank funding is from its Covid-19 fast-track facility where both the entities (World Bank and the government of India) will work on following the best international practice.

The project, according to the document seen by ET, will measure progress on key indicators such as proportion of laboratory-confirmed cases of Covid-19 who responded within 48 hours and the proportion of specimens submitted for SARS-COV-2 laboratory testing confirmed within WHOstipulated standard time.

According to the project document, the government assessment seems to be that outbreaks like Covid-19 will continue in the coming years, and hence there needs to be a long-term strategy to tackle the next wave of the disease.
For example, one of the focus areas of this partnership is on India’s emergency response system to the disease — the aim of this component of the project is to slow down and limit the spread of Covid-19, the joint document says. This, both the parties say, will be achieved through providing immediate support to enhance disease detection capacities through increasing surveillance capacities, port health screening, etc.

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 »