Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
The move has come days after the state government announced to form a special investigation team to probe into the death of Disha Salian, the former manager of late actor Sushant Singh Rajput.
Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
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 Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi high court order dated December 12, 2018, which prohibits online sales of medicines without a licence.
The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
The inspection at Marion Biotech started at around 12 pm and continued for over 10 hours during which six more samples of the syrup were taken, they said.
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation has recommended the conduct of Phase III clinical trials of Russia's single dose COVID-19 vaccine Sputnik Light.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
A joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.
A probe has been initiated by India's drug regulator after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
On Tuesday, Rao said there was a possibility of the PM's visit to Pune, and if that happens, it would be aimed at reviewing the status of the vaccine candidate for coronavirus infection and to know about its launch, production and distribution mechanisms.
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
The more people get vaccinated, the better it will be for the country and the economy, the National Conference vice president said.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
The Central Drugs Standard Control Organisation said while the rights, safety, and well-being of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
Of the 137,000 drug government tested 345 turned out to be fake.
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.
The Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator, may soon ban the production and sale of three medicines in the country. The drugs - cisapride, phenylpropanolamine (PPA) and human placenta extracts - have been controversial medicines for their alleged adverse reactions for several years now.
A joint venture of Synbiotics, a wholly owned subsidiary of Ambalal Sarabhai Enterprises (ASE), and CoDiagnostics, CoSara Diagnostics is the first and only Indian company so far to receive a licence from the Central Drugs Standard Control Organisation (CDSCO) to manufacture coronavirus diagnostic test kits.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
It was also found at many places that spurious medicines, particularly Ayurvedic medicines, are being manufactured without licence from the competent authority.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The voluntary move comes a little more than a year after the Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing, had asked the drug makers to withdraw the 'combination drugs' as they are 'unnecessary' and may pose health hazards. The Drugs Controller General of India had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007.
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).
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
The regulator had issued alerts in June and July of 2015.
The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
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