Biocon Limited has launched its GLP-1 peptide, liraglutide, for the treatment of diabetes and obesity in the Netherlands, as the biopharmaceutical firm positions itself as a global player in the fast-growing diabetes and obesity market currently dominated by the likes of Novo Nordisk and Eli Lilly.
The Central Drugs Standard Control Organisation (CDSCO) has initiated a nationwide campaign to test, inspect, and audit cough syrup manufacturers following concerns about contaminated products and child deaths. The initiative aims to ensure adherence to safety standards and regulatory compliance.
The WHO will take a call on issuing a 'Global Medical Products Alert' on the cough syrup, Coldrif, after receiving an official confirmation from authorities here. The agency issues such alerts for substandard and contaminated medicines.
India's drug regulator CDSCO has recalled three cough syrups and halted their production after the WHO raised concerns about potential contamination and links to child deaths. The WHO is investigating reports of pediatric illnesses and deaths in India potentially linked to contaminated syrups.
Tamil Nadu has formed special teams to monitor drug manufacturers after deaths of infants in Madhya Pradesh were linked to a cough syrup made by a Tamil Nadu-based company. Inspections are being conducted at pharmaceutical firms across the state.
The Central Drugs Standard Control Organisation (CDSCO) will conduct testing, inspection and auditing of cough syrup manufacturers.
The Rajasthan government has suspended the state drug controller and halted the distribution of medicines manufactured by Kaysons Pharma following reports of children's deaths allegedly linked to contaminated cough syrup.
Drug regulator DCGI has asked drug controllers of all states and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical -- N-Nitrosodimethylamine -- in antacid Ranitidine.
Justice Dinesh Pathak, allowing a writ petition filed by M/s Marion Biotech Private Limited, observed that he was surprised that Indian authorities are "trying to validate their proceedings" based on the judgement of the Supreme Court of the Republic of Uzbekistan.
Various industry bodies have sought immediate government intervention through the imposition of anti-dumping duties, claiming India has seen a surge in imports of Chinese goods over the past two weeks.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
As the Drugs Controller General of India (DCGI) is set to crack down on companies to ensure compliance with printing QR codes on top-selling brands to curb counterfeiting, top pharma companies say they welcome the regulator's mandate and that they are on track. They also view it as a positive step to ensure patient safety. Sheetal Arora, CEO of Mankind Pharmaceuticals, which has already adopted QR codes in 20 of their products, stated: "We strongly advocate for mandatory implementation of barcodes and QR codes on medicines as this initiative will not only protect patients but also strengthen the integrity of our healthcare system by reducing circulation of counterfeit drugs."
A critical drug developed on a DRDO technology for radiological and nuclear emergencies has received approval from the Drugs Controller General of India (DCGI), the defence ministry said on Tuesday.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
"We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. "It (rumours of impotency) is complete nonsense," V G Somani, Drug Controller General of India said.
The needle-free vaccine will be available at private centres.
The Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
The DCGI said it has no objection in respect of 'Extension of Shelf Life of Covishield Vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
This is the world's first DNA-based vaccine against the coronavirus, and this three-dose vaccine when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance
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.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
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.
The parties intend to produce over 300 million doses of the vaccine in India per year.
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
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.
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.
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.
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.
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
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 Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
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.
Dominic Xavier ponders the Vaccine Dilemma: Should he take the shot or not?
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