Following the death of 22 children due to consumption of contaminated cough syrups in Madhya Pradesh three months ago, the Union health ministry has proposed amendments in the country's drug rules to ensure a tougher criterion for their over-the-counter (OTC) sales in India.
The World Health Organisation (WHO) has issued an alert against three "substandard" oral cough syrups identified in India and urged national regulatory authorities worldwide to immediately notify it if these are detected in their country.
'Any promotional activity carried out under the pretext of disease awareness, influencer engagement, corporate campaigns, or similar activities that create brand recall/product visibility of the prescription shall also be treated as violations.'
Tamil Nadu government alerted Madhya Pradesh and the Union Health Ministry about the presence of a toxic substance in Coldrif cough syrup, averting a major tragedy, according to state Health Minister Ma Subramanian.
Sandwiched between a Hero MotoCorp showroom and a shop that hires out cooking utensils is a small, dingy building that's been locked up. The non-descript two-room building is a manufacturing unit of Sresan Pharmaceuticals, the pharma company made its Coldriff cough syrup that has allegedly killed 25 children in Madhya Pradesh.
The Indian Medical Association (IMA) has defended a doctor arrested in connection with cough syrup deaths in Madhya Pradesh, attributing the incident to failures in the drugs regulatory system.
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.
The Central Drugs Standard Control Organisation (CDSCO) will conduct testing, inspection and auditing of cough syrup manufacturers.
Domestic majors, such as Himalaya and Baidyanath, are in a dilemma after the UK Medicines and Healthcare products Regulatory Agency made traditional herbal registration mandatory for herbal medicines.
Amid controversy over USPresident Donald Trump's comments linking the use of Tylenol and other related paracetamol products by pregnant women to autism in children, experts and industry executives say that since India's export of the drug to the US is less, it will hardly affect the country's pharma exports to America.
'Once DCGI will give us the permission to restart the trials in India, we will resume the trials,' Serum Institute of India (SII) said in a statement.
The USTR report, released just ahead of the US' April 2 deadline for implementing reciprocal tariffs, has also cited high tariffs and price caps, which have not increased in line with inflation, as key obstacles for US businesses.
Despite these rare occurrences, the pharmaceutical company maintains that extensive clinical trial data and real-world evidence consistently support the vaccine's safety and efficacy.
The WHO on Tuesday issued a product alert over contaminated syrup by an Indian manufacturer, warning that it is unsafe for use, especially in children, and may result in serious injury or death.
The World Health Organisation has issued an alert for four 'contaminated' medicines manufactured by an Indian pharmaceutical company that have been 'potentially linked' with acute kidney injuries and 66 deaths among children in The Gambia.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
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.
AstraZeneca and the University of Oxford, as the trial sponsor, said that they cannot disclose further medical information but confirmed that independent investigations concluded that the trials were safe to restart.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
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.
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.
Ramdev's herbal medicine company Patanjali Ayurved has launched 'Coronil tablet and Swasari vati' medicines claiming they can cure the highly contagious disease within seven days.
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.
United Kingdom-headquartered pharmaceutical giant AstraZeneca (AZ) has admitted that in 'very rare cases' its Covid vaccine can cause a blood clot related side effect but the causal link is unknown, according to court papers being quoted in the UK media.
India is one of the largest manufacturers of pharmaceutical products in the world with the annual production valued at over Rs 2 lakh crore.
AstraZeneca has stressed that patient safety is its "highest priority" and pointed out that regulators around the world "consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects".
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
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 drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom, whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, Wockhardt said in a filing to the Bombay Stock Exchange.
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).
Ashish Mehrotra, MD and CEO, Max Bupa Health Insurance, explains the changes we can expect in health insurance this year.
Inspections only in domestic authorities' presence, visiting US drug regulator told
This is apart from the requirement to stock hydroxychloroquine (200 mg) and Azithromycin (500 mg) tablets for patients requiring ICU management, asymptomatic healthcare workers and asymptomatic household contacts of positive cases.
The budgetary allocation for the sector is Rs 60,908.22 crore, with Rs 6,400 crore earmarked for the centre's flagship health insurance scheme Ayushman Bharat- Pradhan Mantri Jan Arogya Yojna (AB-PMJAY).
An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.
Terming the comments 'factually incorrect and without basis', HUL said Pureit was the world's largest-selling water purifier brand and had been approved for sale by regulatory authorities in countries such as Brazil, Mexico and Indonesia.
Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
The NPPA letter was issued to GSK on Wednesday.
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