Best time to invest in pharma, medical device sector: Sadananda Gowda

Source: Business Standard, Oct 01, 2020

New Delhi: This is the most opportune time to invest in theIndian pharma and medical device sector as the government is extending production linked incentives for new manufacturing units in the upcoming bulk drug and medical devices parks,Union Minister DV Sadananda Gowda has said.

The Indian pharma sector, currently valued at USD40 billion, has the potential to become a global pharmacy hub in the coming years, the Chemicals and Fertilisers Minister said in a statement.

The sector is likely to grow to USD 65 billion by 2024, and to USD 120 billion by 2030, he added.

The medical devices industry in India has the potential to grow at 28 per cent per annum to reach USD 50 billion by 2025,Gowda said.

The Indian pharma and medical device sector has immense potential to contribute towards making India a 5 trillion-dollar economy in the next 4-5 years, he added.

The government is supporting development of 3 bulk drug and 4 medical device parks with state-of-art infrastructure and world-class centres of excellence across the country, Gowda said.

“Government will also provide production linked incentives to eligible new manufacturing units to ensure a level playing field to domestic manufacturers,” he added.

It is expected that the schemes of the government for development of bulk drug and medical device parks will attract cumulative investment of Rs 78,000 crore and can generate about 2.5 lakh employment,he added.

“There is a need for the pharma industry to focus on R & D activities in order to remain as one of the leading global suppliers of medicines,” Gowda said.

The full potential of growth cannot be tapped unless the sector comes up with discovery of new drugs or repurposing in India,he added. Gowda also expressed hope that the Indian pharma sector will be among the first ones to develop and supply low cost vaccines for COVID-19.

Centre plans on tweaking drug policy that exempts foreign medicines from price control

Source: The Economic Times, Aug 06, 2020

NEW DELHI: The government plans to tweak a provision that allows new medicines developed by foreign companies to be exempt from price control for five years after criticism that it goes against the Make in India policy and discourages local drug manufacturers.

The Department of Pharmaceuticals and the National Pharmaceuticals Pricing Authority are in discussions about revisiting paragraph 32 of the Drugs (Price Control) Order of 2013, which lists out the exemptions, people aware of the matter told ET.

The government broadened the five-year exemption from price control for new foreign drugs patented in India through an amendment in January 2019. The amendment removed a requirement that the drugs should have been developed through indigenous R&D. This included orphan drugs used to treat rare medical conditions.

Senior officials in the Department of Pharmaceuticals said the move was aimed at giving Indian patients access to drugs that are available only abroad.

However, domestic drug makers and civil rights activists criticised the amendment and complained of high prices and unequal treatment. Experts said the move went against the government’s Make in India policy because it discourages Indian companies from developing and producing patented drugs. The government would also be helpless in an emergency, they said.

“The move will restrict the government from putting expensive drugs under price control, regardless of a public health emergency. Most likely, it would encourage foreign pharmaceutical companies to manufacture and commercialise their new patented drugs and medical devices in India,” said a pharma expert.
The National Pharmaceuticals Pricing Authority also faces the problem of companies launching products and excluding them from the price control regime without first applying for exemption.

“The companies have tried to utilise it and the government is fighting cases in the court with these companies. The government should scrap this amendment as it has only helped multinationals to launch their products at exorbitant prices by claiming that they are patented products,” another expert said.

Indian API makers benefit as global buyers ditch China

Source: The Economic Times, Jul 29, 2020

MUMBAI: India’s bulk drug manufacturing companies have reported increased enquiries from global customers seeking to reduce their dependency on China, rating company India-Ra, a part of the Fitch Group, said in a report this week.

However, India and other countries still remain largely dependent on China for the raw material used to make drugs, known as active pharmaceutical ingredients (API).

“Indian API players are witnessing benefits of better inventory management and thrust on supply chain continuity from customers. Customers’ procurement strategies are recalibrating and are now moving away from China or seeking alternative sources for the same API,” said Krishnanath Munde, associate director at Ind-Ra.

Price sensitivity among formulation companies is declining amid a receding threat of supply chain disruptions from Chinese suppliers, which had also occurred in the past, he said. Considering that India has the highest number of API facilities approved by the US Food and Drug Administration, it will remain a critical part of the global supply channel, Munde noted.

Indian pharma companies have seen a rush of demand for key drugs used in the treatment of Covid-19 in the past two months.

Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices

Source: The Economic Times, Jul 27, 2020

NEW DELHI: The government on Monday released guidelines for four schemes to boost domestic manufacturing of bulk drugs and medical devices as part of its drive to reduce dependency on imports for these critical products.

“In line with the vision of Prime Minister Narendra Modi, the schemes have been conceptualised for making India ‘atmanirbhar (self-reliant) in the pharma sector, chemicals and fertilisers minister D V Sadananda Gowda said.

The schemes—a production-linked incentive (PLI) scheme and industry park scheme each for bulk drugs and medical devices—seek to make India self-reliant in pharmaceuticals raw materials such as drug intermediates, active pharmaceutical ingredients (APIs) and key starting materials (KSMs), and medical devices.

Currently the country almost entirely depends on imports—mostly from China—for production/supply of 53 critical bulk drugs, while 86% of medical devices, too, are imported.

Bulk drug parks “will be based on plug and play model with prior regulatory approvals, state of art infrastructure, excellent connectivity, affordable land, competitive utility charges, and strong R&D ecosystem and so on”, Gowda said.

This will significantly reduce time and investment cost for setting up new manufacturing units. In addition, new units will be eligible for PLI scheme of the government, he said. “Eligible manufacturers will be selected for the PLI scheme on the basis of marks obtained in the evaluation criteria as per the guidelines.”
Ashok Madan, executive director of Indian Drugs Manufacturers’ Association (IDMA), said the industry has been waiting for detailed guidelines of the schemes notified last week.

“It’s for the first time that an impetus of Rs 10,000 crore is being given to augment API production in the country,” he said.

“Limiting the import content for production of listed 41 APIs/KSMs up to 30% is to encourage local manufacture with value addition for the production Linked Incentive,” Madan said.

The list of 41 products will enable domestic production of 53 key bulk drugs.

“Given the right implementation, India can aspire to be selfreliant in APIs/KSMs in 8-10 years,” Madan said.

The industry would like the government to support utilisation of idle capacities of medium API units with blanket environment approvals “subject to their complying with the overall pollution loads”, he said.

Indian e-health sector projected to grow by 13x to $16 bn by 2025: Report

Source: Business Standard, Feb 05, 2019

Bengaluru: The Indian e-health sector is expected to become a $16 billion opportunity by FY 2025, growing from $1.2 billion, at a compound annual growth rate of 68 per cent, according to a report by research firm RedSeer Consulting.

This growth will be driven by increasing consumer receptiveness towards eHealth models and rising provider and supplier willingness to partner with eHealth platforms. This is further supported by an increased influx of investments and pro-eHealth regulations.

Anil Kumar, founder and CEO of RedSeer said Indian consumers face a host of challenges in the traditional healthcare system – be it the availability of specialists or medicines at a nearby pharmacy or long waiting times to get diagnostic tests done.

“We believe e-Health platforms have a strong potential in changing the experience of the Indian consumer across the entire spectrum of outpatient services, across doctor consultation, diagnostics and pharmacy,” said Kumar. “Over the next 5 years, we project the e-Health market to exponentially grow to a $16 billion-market touching 57 million households, driven by positive reception from both consumers and providers along with supportive government regulations and investments,” he added.

As per RedSeer, the overall Indian healthcare industry is set to grow at 17 per cent CAGR until FY 2025 to reach $353 billion (7 per cent of the expected nominal gross domestic product). The firm prepared the report based on the insights from over 1200 consumers about their ‘eHealth’ experience. The report said the consumers significantly value the benefits of eHealth over the traditional outpatient care system across pharmacy, consultation and diagnostics categories.

One such e-health company is Medlife which is delivering medicines to over 25,000 pin codes and diagnostics in more than 400 towns across the country.

“Medlife is poised to end this year with a GMV (gross merchandise value) run rate of $220 million. We believe E-health and not just e-pharmacy is the mantra for this sector,” said Ananth Narayanan, CEO and co-founder of e-health company Medlife. “Our lab diagnostic business scale-up, expansion of our private label portfolio and the e-consultation platform will allow us to achieve stellar growth from these additional areas. We target to be over a $2 billion player by 2024,” said Narayanan. He said one of the biggest challenges for the sector are the fringe players who do not follow the laws and rules properly and cause a wrong perception of the industry as a whole. “We are eagerly awaiting the legislation on e-pharmacy to continue scaling the business. We believe that technology is key to provide access and affordability in healthcare. We are committed to making this happen,” said Narayanan.

Government’s go-ahead for 4 medical device parks

Source: The Economic Times, Nov 10, 2019

NEW DELHI: The government has given approval for setting up four medical device 20191111-1parks with a view to support Make in India initiative and provide world-class products at affordable price for treatment.

The four parks will be set up in Andhra Pradesh, Telangana, Tamil Nadu and Kerala, sources said, adding that Uttarakhand and Gujarat have also approached the Centre for a go-ahead for such parks.

These parks will provide necessary infrastructure, where companies can easily plug and play, sources said.

This will not only cut import bill but will also help in easy access to standard testing facilities and reduce cost of production, they said.

The project of Andhra Pradesh Medtech Zone for creation of Common Facility Centre (CFC) for Superconducting Magnetic Coil Testing and Research was given in-principle approval recently.

The scheme proposes to provide Rs 25 crore or 70 per cent of the project cost of setting up of CFCs, whichever is less, for creation of common facilities in any upcoming park.

According to estimates, the medical devices retail market in the country is of around Rs 70,000 crore. The domestic medical devices industry is very small even though India is the fourth largest market in Asia.

India is largely an importer of medical devices, with domestic industry accounting for about 2 per cent of the global industry which stands at USD 250 billion, as per the estimates.

Govt plans to set up body to regulate medical devices sector

Source: Business Standard, Sept 26, 2019

New Delhi: The government is planning to set up a Medical Devices Authority (MDA) for the entire spectrum in the medical devices sector — gauges, weighing machines, orthopaedic implants or whatever.

It will, however, not have powers on pricing. That will continue to be vested with National Pharmaceutical Pricing Authority (NPPA), senior officials said.

The proposed body will be separate from the Central Drugs Control Standard Organisation (CDSCO), which will continue to be the regulator for drugs.

The Bureau of Indian Standards (BIS) will still frame guidelines but these would be regulated by MDA. The arrangement would be on the lines of food items, where BIS designs the standards but these are enforced by the Food Safety and Standards Authority of India. Read the rest of this entry »

A year on, Ayushman Bharat faces multiple challenges ahead

Source: The Hindu Business Line, Sept 24, 2019

New Delhi: The free cashless health insurance scheme for the poor, Pradhan Mantri Jan Arogya Yojana (PM-JAY) or Ayushman Bharat completed a year on September 23. The National Health Authority (NHA) which implements the scheme stated that 46.4 lakh had received treatment through hospitalisation under the scheme. However, the past year has thrown up multiple challenges for the plan.

One such challenge is to strengthen its fraud control mechanisms. NHA said in its press release that patients availed free treatment worth nearly ₹7,500 crore . This means that the average cost of treatment per patient in the scheme comes up to ₹16, 164. The average promised annual cover of five lakh rupees per family is way higher than the average cost of treatment of a patient, considering that it is highly unlikely that all family members will avail the benefit in the same year. Read the rest of this entry »

Serum Institute opens world’s largest vaccine facility

Source: Financial Express, Sept 10, 2019

Pune: Serum Institute of India (SII) has opened the world’s largest vaccine manufacturing facility with an investment of Rs 3,000 crore in a capacity expansion move aimed at capturing 10-15% share of the international market.

The institute is getting ready to export Made in India vaccines to regulated markets like Europe and the US from its new facility, which will produce half-a-billion doses annually. Spread across 2 million sqft, the facility will cater to 150 countries.

The new multifunctional production facility for vaccines at the Poonawalla Bio-Tech Park at Manjri was inaugurated by Union minister for health and family welfare Harsh Vardhan on Monday. Read the rest of this entry »

Govt to regulate four more medical devices

Source: The Hindu Business Line, Dec 11, 2018

New Delhi: Four more medical devices — nebulisers, glucometers, digital thermometers and blood pressure monitors — have been notified in the latest addition to product categories under the Drugs and Cosmetics Act, which will ensure their quality and performance.

This means such devices will be under regulation and their import, manufacture and sale will be under scrutiny. Twenty-seven product categories are now notified under the Act, said an official from the Ministry of Health and Family Welfare (MoHFW). The categories which are not notified for regulation are sold in the open market without adequate checks and balances, including for instance, pacemakers. “We are moving in the direction to now regulate all implantable devices,” said S Eswara Reddy, Drug Controller General of India (DCGI). Read the rest of this entry »