The Central Consumer Protection Authority (CCPA) on Thursday directed e-commerce entities to sell specified ayurveda, siddha and unani drugs only after customers upload valid medical prescriptions from registered doctors on the platforms.
Thousands of police personnel and CCTV cameras were deployed and traffic regulated across states on Tuesday to ensure public safety and prevent any untoward incident as the country geared up to welcome 2025.
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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.
India and the United States will finalize the contours, schedule of negotiations, and terms of reference for a proposed bilateral trade agreement (BTA) during a three-day meeting beginning Tuesday. The agreement is expected to be finalized in two tranches, with the first phase focusing on goods trade. The US team, led by Assistant US Trade Representative for South and Central Asia Brendan Lynch, will be in India from March 25-29 to discuss the agreement. Both countries are aiming to conclude the first phase of the agreement by fall 2025.
India currently does not have any XBB 1.5 variant-based vaccines available.
The move has come a fortnight after Ranbaxy pleaded guilty in the US to making fraudulent statements to the US drug regulator about testing drugs.
"The new structure will substantially reduce taxes on the middle class and leave more money in their hands, boosting household consumption, savings and investment," Sitharaman said presenting what was dubbed as 'reformist' budget for the next fiscal in Lok Sabha.
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.
Lauding the scientists and technicians for the 'Made in India' vaccines, he said the country is proud of them.
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
Indian pharma firms under European drug regulator's scanner.
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
Under the proposed rules, individuals or companies will have to register with the central licensing authority to run an e-pharmacy; state-wide registration is not required.
An expert panel of the Central Drugs Standard Control Organisation on July 29 had recommended granting permission for conducting the study.
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.
The seven states are Bihar, Jharkhand, Maharashtra, Punjab, Tamil Nadu, Uttar Pradesh and West Bengal.
A joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.
Zydus Cadila has agreed to bring down the price of its COVID-19 vaccine to Rs 265 a dose following persistent negotiations by the government but a final deal is yet to be reached, sources said on Sunday.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
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.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
Unlike India, the US is a free-pricing market.
It brought more drugs under control, cracked foreign firms' patents and introduced new regulations when MNCs acquire Indian cos.
'Whichever company offers better incentives, the chemist would prefer it.'
Roche said the Indian regulatory authorities had approved Biocon and Mylan's products as Trastuzumab, but it was unclear if these met the criteria for biosimilar products.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
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.
Double Olympic 800 metres champion Caster Semenya has lost her appeal to the Swiss Federal Tribunal (SFT) to set aside a 2019 Court of Arbitration (CAS) ruling that female athletes with high natural testosterone levels must take medication to reduce it.
A notice issued by the Indian Health Ministry at the weekend said that a government-appointed committee of experts had found that the banned combinations were "likely to involve risk to human beings, whereas safer alternatives to the said drug are available."
Apart from favipiravir and remdesivir, its key Covid-19 products, DRL has already launched nutraceutical products and hand sanitisers during the pandemic.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
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).
"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.
Gland Pharma beat muted expectations for Q2FY25. There was increased Ebitda (Earnings before interest, taxes, depreciation and amortisation) loss at Cenexi, the CRAM subsidiary. However, overall Ebitda margin was better than expectations at 21.1 per cent. But given two years of earnings decline in FY23 and FY24, the business may have bottomed and upper-teens EPS (earnings per share) growth looks possible over next two financial years.
Codeine-based formulations are under the scanner for misuse as a narcotic product.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
