Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets. While R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth of generics and injectable products, concerns such as price control and customs duties on medical equipment will continue to bother the healthcare industry in 2023. The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage, improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
The central drug regulator has issued show cause notices to these two importers and asked to stop the import of rapid test kits based on the observation by the apex health research body Indian Council of Medical Research (ICMR).
India will export anti-malarial drug hydroxychloroquine, high in demand globally, only to foreign governments and not to private companies, as the product is under prohibited or banned category of exports, sources said. Although exports of this medicine is completely banned, India has decided to export this anti-malarial drug in sync with its global commitment to deal with the coronavirus pandemic.
Fund managers said investors remained positive on the pharma manufacturing activity in India, which further strengthened during the Covid-19 period, on account of restrictions imposed on pharma imports from China.
The CoWIN portal will be made available in Hindi and 14 regional languages by next week, while 17 more laboratories will be added to the INSACOG network to monitor the variants of COVID-19, the health ministry said on Monday.
The $66 million (Rs 272.8 crore) Leiner Health Products is likely to sue DRL for the early divorce (the agreement has lasted only four years) from the alliance.
The proposed merger would likely harm future competition
The Bharatiya Janata Party in Maharashtra objected to the pharma executive's grilling by Mumbai police, saying the Shiv Sena-led government in the state was playing politics amid the pandemic.
Terming the situation as scary, Nath also said there was a shortage of Remdesivir injections used in the treatment of coronavirus, and alleged that the key anti-viral drug and oxygen were available only on paper and not in reality.
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
During an over three-hour hearing on the matter relating to oxygen crisis and shortage of medicines to treat COVID-19 patients in the national capital, the court observed that the "problem lies with the Delhi government" and directed nodal officer Udit Prakash to ensure supply of oxygen by cylinders to hospitals and nursing homes "without fail".
Like pharmaceutical companies globally - which used to enjoy a preferential exchange rate in Venezuela - Indian producers have been left badly stung by the collapse of the bolivar currency
The further distribution of vaccine to the districts will be done as per the registered beneficiaries, for which a separate communication will be done shortly, the letter stated.
Indian auto and pharma industries import several critical components and raw materials from China.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
On her maiden visit to India, US Food and Drug Administrator Margaret A Hamburg has said recent lapses in quality by a handful of pharma companies has overshadowed the good things done by other Indian companies, who emphasise on quality products and practices.
"The president pledged America's steadfast ongoing support for the people of India, who have been impacted by the recent surge in the COVID-19 cases," White House Press Secretary Jen Psaki told reporters at her daily news conference.
Pharma industry lauds idea, but suggests looser rules on ground
Few drugs in the market are not approved by the authorities and can be life-threatening.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
Expectations of Healthcare sector from Union Budget 2013-14.
It is one of 42 drug-making factories in India that the FDA has banned in recent years
Serum Institute already has two deals of 100 million each to supply the Oxford-AstraZeneca and the Novavax vaccine to Gavi-Covax at $3 per dose.
At a time when the country's medical infrastructure has become incapable of handling the pressure of Covid's deadly second wave, a parallel wave of conmen, black marketers and counterfeiters can be witnessed across the country. Geetanjali Krishna reports.
In a fresh crackdown on the multi-billion National Rural Health Mission scam, the Central Bureau of Investigation on Friday carried out as many as 30 raids across five different cities in Uttar Pradesh.
Torrent to buy Ranbaxy's anti-bacterial generic
The government is targeting 1,200 technical collaborations between Japanese companies and Indian investors for over Rs 42,000 crore, 200 joint ventures with overseas investors for Rs 14,000 crore, and another Rs 14,000-crore investment from about 50 multinational companies.
The central government should provide for free vaccination to all Indian citizens and greatly ramp up RT-PCR testing in both rural and urban areas, a group of former civil servants said on Thursday in an open letter to Prime Minister Narendra Modi.
The Covishield maker's forte throughout the past half a century has been a combination of affordable vaccines and high volumes. Its tetanus, diphtheria and measles vaccines are known throughout the world, reports Sohini Das.
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.
'If the almost literally heart-stopping Suez block has any positive outcome, it is to be hoped that it will accelerate the setting up of a fab (perhaps Taiwanese) in India,' asserts Rajeev Srinivasan.
The ICMR is working on a war footing to develop the testing ecosystem -- especially for the screening blood tests. NIV, Pune, is in the process of validating antibody-based screening kits.
The new US bio-terrorism law, which mandates prior registration of food suppliers with the USFDA, is likely to adversely affect the Indian food and marines exports, warns a leading non-government organisation EAN-India.
Not to say that India couldn't have handled the situation better, but on average, it didn't do anywhere near as badly as the naysayers make it out argues Rajeev Srinivasan.
Prime Minister Narendra Modi also thanked Brazilian President Michel Temer for "understanding India's aspiration" for membership of the Nuclear Suppliers Group.
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