It has been approved by the European Medicines Agency for conditional marketing authorisation.
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
While the opposition party asked the government to stop boasting about India being a pharmacy to the world and take strictest action, the ruling party accused it of deriding India in its "hate" for Prime Minister Narendra Modi.
With an eye on improving quality assurance in the wake of increased global scrutiny on Indian pharma products, the Centre on Tuesday said that Schedule M of the Drugs and Cosmetics Act, 1940 will be made compulsory for small and medium scale manufacturers in a phased manner. Union Health Minister Mansukh Mandaviya has asked micro-small and medium enterprises in pharma manufacturing to move towards good manufacturing practices (GMP) through self regulation. "This will help in quality assurance and also reduce compliance burden," Mandaviya.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
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The drug regulatory agencies of India and Canada are planning to collaborate on improving the quality of drugs traded between the two countries, besides helping the industry in both the countries to tap the opportunities in the field of generic medicines and drug development.
Bangalore-based Stempeutics Research received clearance from the Drug Controller General of India to conduct human clinical trials to develop drugs using stem cells. With this, India became the first country after the US to allow human clinical trials to develop drugs by using dormant cells in the body that have natural regeneration capabilities. Once injected into a patient, the stem cells can be controlled with a simple magnet to direct them to the damaged area and cure
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
In what could be the beginning of fresh troubles for Ranbaxy Laboratories, which has just managed to settle long-pending issues with the US Department of Justice after agreeing to pay a penalty of $500 million, the health ministry in India, too, has decided to initiate a probe.
DCGI has approved to market Itolizumab (ALZUMAb) injection 25mg and 5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19, Biocon said in a release.
With regulatory uncertainties clouding the future of online pharmacies, deals in the space are showing signs of slowdown, as also fresh investment from private-equity (PE) firms and venture capitalists (VCs). The data from Venture Intelligence shows so far in 2023 (as of June 13) there has been one deal with PE-VC funding. In 2022 there were four, a sharp fall from the 12, totalling $1,520 million, the sector had attracted in 2021.
Concerned about the rise of antibiotic resistance and the time it takes for drugs developed abroad to reach Indians, the government is considering holding its own clinical trials. Clinical trials for new drugs have so far primarily been conducted only by private Indian or foreign drug firms. But given the stringent nature of India's regulatory environment for clinical trials, several pharmaceutical companies have moved their trials out of India. As a result, only 1.2 per cent of global clinical trials take place in India.
Experts believe the move will have little impact given limited production of generic drugs and authority of doctors in prescribing medicines.
As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation.
They said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by the WHO, the committee will advise and recommend further course of action to the Drugs Controller General of India (DCGI).
This government's approval for use of the antiviral drug comes at a time when India's daily COVID tally is crossing the 3-lakh mark.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
Firms, foreign and Indian, reiterate they follow the rules fully. Earlier, SC had rapped govt for gaps in law and enforcement, including on compensation.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
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.
It said clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
NPIL had announced that it would team up with the French company to develop a drug for the epidemic about six months ago, following the spread of the disease, mainly in southern India and Maharashtra in the last two years. Currently, drugs are not available to effectively treat the disease and doctors in the country administer viral disease drugs such as paracetamol and other anti-biotics to check the infection.
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
While the office of the Drugs Controller General of India is still struggling to accumulate data, compensation had been paid only in 50 per cent of the clinical trial death cases so far, sources said.
The solution to Manipur's problems lies in the government giving concessions to Meitis in jobs and education and to accept autonomy for the tribal dominated areas inhibited by the Kukis, suggests Colonel Anil A Athale (retd).
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The Drugs Controller General of India is considering the recommendations of its advisory body to revoke the suspension of the sale of analgin-based medicines in the country.
The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
Swiss drug maker Novartis might face tough action from the country's drug regulator for allegedly giving fake documents while seeking renewal of registration for Tiamulin Hydrogen Fumerate (80 per cent granules), sources said.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
The World Health Organization has given five more months to the Drugs Controller General of India to upgrade its performance to international standards. The extension of the current deadline of October-end came after a visiting WHO team found the modernisation programmes of the Indian drug regulator on track.
The magistrate court has remanded the accused Pakistani national Subair, who was arrested by the Narcotics Control Bureau to 14 days of judicial custody.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
The company claims that when the Nitric Oxide Nasal is sprayed over nasal mucosa it acts as a physical and chemical barrier against the virus.
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