Relief for pharma cos as Delhi HC says cough syrup ban applies prospectively
In a relief to pharma companies, including
Glenmark Pharmaceuticals
and
Zuventus Healthcare
, the
Delhi High Court
on Thursday held that the government's
April 15 notification
that prohibited the manufacture, sale, and distribution of all
fixed-dose combinations
(certain cough syrup brands) for those below four years of age will apply prospectively.
The notification issued by the
Ministry of Health and Welfare
, which came into effect immediately on the said date, mandated a manufacturer to include a warning stating 'fixed-dose combination shall not be used in children below four years of age' on the label and package insert or promotional literature of the drug.
A Division Bench led by Chief Justice DK Upadhaya accepted the concerns of the manufacturers that the notification cannot applied retrospectively as some stocks have been manufactured and were in the market before the ban came into effect on April 15. However, the court asked the companies to issue an advisory to doctors, chemists and retailers that fixed dose combination of drugs shall not in 'any circumstances' be prescribed/administered to children below four years of age.
by Taboola
by Taboola
Sponsored Links
Sponsored Links
Promoted Links
Promoted Links
You May Like
Play War Thunder now for free
War Thunder
Play Now
Undo
Additionally, the judges asked the manufacturers to publish an "unambiguously worded notice" in two national newspapers—one in English and one in Hindi— having nationwide circulation. The size of the notices must be designed to attract the attention of readers, the court said.
The notice and advisory shall be published within a week, the court said.
Live Events
However, the manufacturers have been directed to 'compulsorily comply' with the notification by mentioning the warning on all their labels and packaging of all stocks manufactured and circulated after April 15.
The pharma companies must file an affidavit furnishing details of the stocks manufactured, sold or have been in circulation before April 15, the court said.
However, the court clarified that any such public notice published by the pharma companies should not be construed as an advertisement and would not amount to any breach of their drug license conditions.
If the pharma companies abide by the conditions regarding the notice, advisory, and undertakings, irrespective of the manufacture and sale of the drug in question, no coercive measures against them will be taken, the court. The court will hear the case for compliance on May 15.
Senior counsel Amit Sibal and counsel Ajay Bhargava alleged that the drug manufacturers and other stakeholders were not given any opportunity of hearing before the notification was issued.
The directions came on a couple of appeals filed by Glenmark and Zuventus challenging the validity of the April 15 notification issued by the Department of Health and Welfare that prohibited the use of all formulations of the fixed dose combination of chlorpheniramine maleate plus phenylephrine hydrochloride in children below four years of age.
The restrictions issued under Section 26A of the
Drugs and Cosmetics Act
, 1940 were imposed on the recommendations of the Drugs Technical Advisory, citing safety concerns.
The prohibited fixed drug combination is a commonly used formulation found in various over-the-counter drugs used to treat colds and allergies. The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark Pharma.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
2 hours ago
- Time of India
Sugamya worksheets for children with special needs
Lucknow: State govt is championing inclusive education by providing nearly 2.96 lakh children with special needs with 'Sugamya' worksheets. Developed in collaboration with Unicef, the initiative aims to enhance foundational learning while fostering confidence and self-esteem. Basic education minister Sandeep Singh said Sugamya worksheets would ensure equal educational opportunities for children with disabilities in a significant step toward building an inclusive and empathetic society. Covering Hindi and mathematics for students from classes 1 to 8, the initiative includes 1,900 worksheets designed for various categories of children with disabilities (excluding those with complete visual impairment). The worksheets are in simple language and carry vibrant visuals and engaging formats to make learning accessible and enjoyable.
Time of India
3 hours ago
- Time of India
Think olive oil is healthy? Shockingly study says it contributes to obesity
Image credits: Getty Images It's time for an oil change, really. A recent study has stunned people with the news that olive oil actually contributes to obesity. For years, olive oil has been consumed as a healthy alternative to other cooking oils. According to the North American Olive Oil Association, more than 50% of American households use olive oil due to its flavour and health benefits. According to a study published in the National Library of Medicine, olive oil has anti-inflammatory, hepatoprotective, renoprotective and anti-neurodegenerative agents. However, a recent study published in the journal Cell Reports revealed that eating a high-fat diet containing a huge amount of oleic acid- a type of fatty acid found in olive oil, can cause more obesity than other types of dietary fats. Oleic acid, a monosaturated fat associated with obesity, leads the body to make more fat cells. High levels of the acid boost a signalling protein, AKT2 and reduce the activity of a regulating protein LXR, to result in the faster growth of the precursor cells that form new fat cells. "We know that the types of fat that people eat have changed during the obesity epidemic. We wanted to know whether simply overeating a diet rich in fat causes obesity, or whether the composition of these fatty acids that make up the oils in the diet is important. Do specific fat molecules trigger responses in the cells?" said Michael Rudolph, Ph.D, assistant professor of biochemistry and physiology at the University of Oklahoma College of Medicine and member of OU Health Harold Hamm Diabetes Center to Medical Xpress. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 5 Books Warren Buffett Wants You to Read In 2025 Blinkist: Warren Buffett's Reading List Undo The shocking research Image credits: Getty Images Rudolph and his team which included other collaborators at Yale University School of Medicine and New York University School of Medicine, carried out the research by feeding mice a variety of specialized diets rich in particular individual fatty acids, including those found in coconut oil, peanut oil, milk, lard and soybean oil. Oleic acid was the only one that led to precursor cells that gave rise to fat cells to proliferate more than other fatty acids. "You can think of the fat cells as an army," explained Rudolph. "When you give oleic acid, it initially increases the number of 'fat cell soldiers' in the army, which creates a larger capacity to store excess dietary nutrients. Over time, if the excess nutrients overtake the number of fat cells, obesity can occur, which can then lead to cardiovascular disease or diabetes if not controlled." He suggested consuming fats in moderation and from a variety of sources. "Relatively balanced levels of oleic acid seem to be beneficial, but higher and prolonged levels may be detrimental. If someone is at risk for heart disease, high levels of oleic acid may not be a good idea." One step to a healthier you—join Times Health+ Yoga and feel the change
Time of India
3 hours ago
- Time of India
‘Avoid rath yatra if you have Covid symptoms'
Gandhinagar: While urging people to take precautions against Covid-19, state health minister Rushikesh Patel on Wednesday advised those with Covid-like symptoms and those with co-morbidities to refrain from participating in Lord Jagannath's rath yatra on June 27. "People who have symptoms like those of Covid-19 must refrain from participating in the rath yatra. Also, people with co-morbidities, the elderly, and those who have flu-like symptoms must remain in their houses and watch the rath yatra," Patel said while talking to reporters in Gandhinagar on Wednesday. He added that this will ensure that people who have symptoms will not transmit it to others, and co-morbid people will also not be exposed to infections. Meanwhile, after participating in the jal yatra in Ahmedabad on Wednesday, minister of state for home Harsh Sanghavi said that the rath yatra is a centre of devotion for lakhs of people. "Preparations are being made for the rath yatra to be held on June 27. It is the biggest procession from the perspectives of both devotion and administration," the minister said. With more than 1,200 active Covid-19 cases in Gujarat at present, Patel said that although the variant responsible for the surge is less severe than previous ones, people need to take precautions and isolate themselves if symptoms emerge. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Giao dịch vàng CFDs với mức chênh lệch giá thấp nhất IC Markets Đăng ký Undo "We are in touch with the Union health ministry. The variant responsible for these new cases belongs to the Omicron family, which is less severe," he said. Although the variant is not very harmful, people need to take precautionary measures. Patel said that health infrastructure like beds, medicines and medical oxygen supply is in place.
