India's apex drug regulator cautioned against antibiotic self-medication and their use for conditions where antibiotic treatment is not clinically indicated, particularly viral infections, the common cold and fever.
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
As many as 150 applications are stuck at evaluation stage, says official.
The Union health ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 milligrams for human use, citing health risks.
Among the commonly used analgesic formulations (painkillers) found NSQ are combinations of paracetamol with ibuprofen, diclofenac and mefenamic acid. Medications using these combinations are commonly used to treat fever, mild migraine, period and muscle pain.
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.
Over 20 drug companies marketing anti-obesity drug sibutramine under a variety of brand names are likely to soon face a ban on selling the medicine.
'Anti-cancer, anti-diabetic, and other drugs suspected to be spurious were seized from the raid carried out at the firm.'
Hospitals and blood banks can now only charge processing fees for blood as the apex drug regulator has decided to do away with all other fees to check the practice of overcharging.
The Supreme Court of India has ruled that stem cell therapies for Autism Spectrum Disorder (ASD) can only be offered within approved and monitored clinical trial settings, deeming any other use unethical and potentially malpractice.
The Drugs Controller General of India, the apex drug regulator, has included a new clause in the trial approval letters, making these firms also accountable for any possible adverse event.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as 'cocktail' drugs.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
"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.
The controversy has sparked reactions across states. The famous Mankameshwar temple in Uttar Pradesh has now banned offerings of 'prasad' bought by devotees from outside and said they can offer homemade 'prasad' or fruits.
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In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance, an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants.
'Even as the Supreme Court's anti-punitive demolition judgment nears its first anniversary, no formal contempt proceedings have been initiated either by the Supreme Court or any high court against officers or demolition squads who have acted in violation of it.'
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 new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
The central drug regulator has issued show cause notices to these two importers and asked to stop the import of rapid test kits based on the observation by the apex health research body Indian Council of Medical Research (ICMR).
Nestle India has been arguing that ban order was arbitrary.
The bone of contention is product approvals, which pharma and neutraceuticals companies say cannot be re-introduced through the regulation route
The high court had given the company six weeks for retesting.
A bench comprising Justices Sanjiv Khanna and Dipankar Datta took note of the submissions of lawyer Prashant Bhushan, appearing for NGOs 'Common Cause' and the Centre for Public Interest Litigation, that the plea needed to be listed for hearing at the earliest.
Face NPPA fine for overcharging on anti-asthma drug
The Supreme Court on Wednesday agreed to hear on February 17 a fresh plea of a Congress leader seeking investigation under the supervision of a sitting apex court judge against the Adani group of companies in light of the allegations made by the US-based Hindenburg Research.
A plea has been filed in the Supreme Court seeking investigation under the supervision of a sitting apex court judge against the Adani group of companies in light of the allegations made by the US-based Hindenburg Research.
'Gift-giving' - from free dinners and drug samples to promotional merchandise - seems to be driving drugmakers' marketing - a marketing prescription deeply entrenched in the industry. This is a well-oiled racket that sees pharmaceutical (pharma) companies 'gifting' doctors to push their respective drugs under the guise of marketing. But is there a cure in sight to end this unhealthy alliance? The recent controversy following the income-tax raids on Bengaluru-based drugmaker Micro Labs, makers of popular paracetamol brand Dolo-650, has brought this to the fore, again.
There are 12 sites across India, including private and public hospitals, conducting Phase 1 and 2 human clinical trials for Bharat Biotech's Covaxin. Based on an earlier letter by the Indian Council of Medical Research (ICMR) to the 12 sites, volunteer recruitments for the clinical trials were to begin by July 7. At least three sites are yet to kick-start the process.
Channels across the board from news to general entertainment, music and movies telecast half-hour to one-hour advertorials promoting these products, mainly during non-prime time hours
The introduction of e-pharmacy, to protect the interest of a handful of players, would hamper the interest of 800,000 chemists and 80 lakh workers and their families
Easing restrictions, all private hospitals were on Tuesday allowed to give the vaccines if they adhere to the laid down norms, while the 9 am to 5 pm timing was also done away with.
Joint Secretary in the health ministry Lav Agarwal said 154 new positive cases of the disease have been reported due to the transit-related history of those who attended the Tablighi Jamaat congregation. These include 23 new cases from Jammu and Kashmir, 20 from Telengana, 18 from Delhi, 65 from Tamil Nadu, 17 from Andhra Pradesh, nine from Andaman and Nicobar Islands and two from Puducherry.
The Supreme Court on Friday refused to entertain the appeal of Sushant Singh Rajput's sister challenging the Bombay high court order which refused to quash a first information report lodged against her on the complaint of actress Rhea Chakraborty, the late actor's girlfriend.
Maggi re-entered the market on November 9.
Harjit Singh Chhabra, head, Sadar Nishkarm Welfare Association, estimated that losses could go up to hundreds of crores.
This is second time in a month when a packaged food co has complained
His nomination was announced by the outgoing President, Anthony Wreford, at the MCC Annual General Meeting at Lord's in May this year.
Union Environment Minister Harsh Vardhan welcomed the apex court's order and urged people to abide by the SC guidelines and 'give green Diwali and our environment a chance'
Markets across the globe gained after China Securities Regulator removed its four-day-old circuit-breaker system.
