No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration with the licensing authority, as defined in clause (b) of rule 21.
The Drugs Controller General of India, the apex drug regulator, has included a new clause in the trial approval letters, making these firms also accountable for any possible adverse event.
India is one of the largest manufacturers of pharmaceutical products in the world with the annual production valued at over Rs 2 lakh crore.
The minister said that his ministry will clear its stance on Patanjali's ayurvedic drugs after reviewing the report sent by it.
The US Food and Drug Administration has asked USV to probe employees who might have been responsible for inaccurate data reporting.
Pfizer's blockbuster drug Viagra (sildenafil citrate), hitherto approved for use in treatment of erectile dysfunction, may soon acquire a new identity as a "life saving drug" in treating pulmonary arterial hypertension in children.
It has hired consultants to advise it on a strategic project and compliance issues in the US. It also needs to improve employee morale.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
If I follow US standards, I will have to shut almost all drug facilities: G N Singh
The government regulates prices of all other medicines.
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 proposed merger would likely harm future competition
In addition to the US drug regulator, Food and Drug Administration, and rival pharma majors that appear keen to launch litigation against Indian company Ranbaxy, a US citizen has joined the bandwagon by filing a case in the world's biggest drug market.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
The antiviral drug may cost around Rs 55,000 for an 11-dose course, or Rs 5,000 per injection -- much less than the price of imports from Bangladesh, reports Sohini Das.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
Pilots might soon be asked not to use perfume, mouthwash and tooth gel as that may result in positive breath analyser test. The Directorate General of Civil Aviation (DGCA) has sought comments on a draft Civil Aviation Requirements (CAR) wherein it has also proposed barring crew from using any "drug/formulation or use any substance such as mouthwash/tooth gel/perfume or any such product which has alcoholic content". Comments have been sought on the CAR, which pertains to procedure for medical examination of aircraft personnel for alcohol consumption, till October 5.
Fixed-dose combinations are medicines that come mixed in a certain proportion.
Drug Controller General G N Singh said the regulator is addressing all the pending issues to liberate the pharma sector and to simplify export regulations which will be reflected in the forthcoming policy.
A 40-year-old man who was a volunteer in the third phase of the ''Covidshield'' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions.
Dr Reddy's Laboratories is in a pact with Russian Direct Investment Fund to sell the first 125 million people doses (250 million vials) of Sputnik V in India.
The National Pharmaceutical Pricing Authority (NPPA) on Thursday said it has increased prices of 62 drugs, which are mainly based on indigenously manufactured insulin, giving a filip to domestic firms.
With these 18 drugs, the government now has brought in 467 medicines under the price control.
Sun Pharma could have to withdraw cancer drug as J&J re-enters after temporary eclipse
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The move is expected to delay the introduction of low-priced medicines in the market.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
In his press conference on Wednesday, Trump targeted drug-makers and vowed to bring back production in the US.
Union Health Minister Mansukh Mandaviya on Tuesday told Bharatiya Janata Party MPs that Covid vaccination for children is likely to start soon, sources said.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Indian government has set up a panel to fix prices of patented drugs in the country.
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.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
In the clearest indication from the European Commission yet that a resolution to the ongoing dispute between New Delhi and Brussels regarding generic drug seizures had been reached, a senior EC official told reporters on Wednesday that the EU was "open to changing" the offending regulation.
The National Pharmaceutical Pricing Authority, which regulates the prices of medicines, has identified around 70 anti-cancer drugs, including anti-breast cancer medication Letrozole and anti-blood cancer drug Imatinib, for detailed price analysis.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
