The government regulates prices of all other medicines.
The government has capped the trade margin on oxygen concentrators at 70 per cent in order to keep in check the price of the much in demand critical life saving component amid the second wave of the coronavirus pandemic. The trade margin has been capped at 70 per cent on price to distributor level on oxygen concentrators. In an official release, the chemicals and fertilisers ministry said the decision has been taken in view of the extraordinary circumstances arising due to the pandemic which has resulted in volatility in Maximum Retail Prices (MRP) of oxygen concentrators.
The western world had largely considered India to be a production hub, and also, a good potential geography for clinical trials, and a big market. But in Covid-19 research, Indian companies and government researchers are also researching new drug candidates and potential vaccines, says Prosenjit Datta.
The regulator is now probing 24 hospitals, including Max Hospital in New Delhi and Lilavati in Mumbai, for allegedly overcharging patients for stents
While Lupin is working on a Remdesivir powder for inhalation, Glenmark has tied up with a Canadian Biotech firm for nitric oxide nasal spray that reduces Sars-CoV-2 viral load and thus transmission.
Leading pharmaceutical firms such as Cipla and Ranbaxy are among the firms pulled up by the drug price regulator National Pharmaceuticals Pricing Authority (NPPA) for overcharging.
Details on prices sought as 10 generic drugs become up to 83 times costlier in 6 months
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India seeking emergency use authorisation for their COVID-19 vaccines.
The department of pharmaceuticals turned down a review petition by drugmaker Cipla against a price fixation order by the National Pharmaceutical Pricing Authority, slashing the price of Dytor Plus, a medicine for kidney and heart ailments.
The finance ministry on Friday withdrew expenditure curbs on various departments and ministries imposed in June in the wake of the COVID-19 second wave, reflecting improvement in public finances and the urgency to step up growth.
The vaccine would be first made available to the vulnerable population and eventually, it would be available in the private market for all.
Germany's drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by India's pharmaceutical research company GVK Biosciences were "insufficient".
A panel led by the secretaries of the DEA and the DIPP would conduct a quarterly review on the pending proposals.
India's medical devices imports surged 41 per cent to touch Rs 63,200 crore in 2021-22, led by a 48 per cent year-on-year (YoY) jump in imports from China to Rs 13,538 crore, the commerce ministry data analysed by the Association of Indian Medical Device Industry (AiMeD) has showed. Local industry players say this has led to several small and medium units to shut shop. Rakesh Vaid of Usha Fabs, a garments exporter, had started making N95 masks in his Gurgaon factory during the peak of the Covid-19 pandemic.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
NPPA denies price hike on Sanofi, Novartis, and Allergan products.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The growth prospects are particularly high for Indian companies in the speciality and complex generic drugs segment in the US, the report said.
People close to Shanghvi reveal he is known to make surprising moves both inside and outside the pharma industry.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
Ankleshwar plant is the third such facility to face action
India has asked Indonesia to remove barriers on import of pharma products, in a bid to boost trade ties between the two countries.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
Refusing to divulge identity of the companies, sources indicated that three of them are based in Delhi and the remaining are in Maharashtra.
The founders of Gland Pharma, led by Ravi Penmetsa, and KKR, together own 96 per cent of the company.
This move is expected to benefit 22 lakh cancer patients in the country.
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.
While sales in the domestic market declined 4.2 per cent during the April-July period, exports grew steadily at 9.5 per cent during the same period.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID-19," tweeted the minister.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for it's Hydrocortisone Butyrate Cream USP (0.1 per cent), abbreviated new drug approval from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a statement.
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The move is expected to delay the introduction of low-priced medicines in the market.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
The Saveetha Institute of Medical and Technical Sciences. The Indian School of Mines, Dhanbad. Vinay Umarji explains why these two universities have made India proud.
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
Domestic firms Aurobindo Pharma, Glenmark Pharmaceuticals and Natco Pharma have received US health regulator's approval to market their generic Rizatriptan Benzoate orally disintegrating tablets used for treating migraine in the American market.
The IPO rush will continue in September with two more companies Vijaya Diagnostic Centre and Ami Organics launching their initial share-sales on Wednesday to raise a total of Rs 2,465 crore. This comes after eight companies including Devyani International, Nuvoco Vistas Corporation and CarTrade Tech floated their initial share-sales last month to mobilise Rs 18,243 crore. So far in the current fiscal, a total of 20 companies have mopped up more than Rs 45,000 crore through IPOs. This is much higher than Rs 31,277 crore raised by 30 firms in the entire 2020-21.
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
