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The Drugs Technical Advisory Board (DTAB), India's apex drug advisory body, in its meeting last month was also considering a proposal for exempting dried Ivy leaf extract sugar free cough syrup from the requirements of a prescription.
Aspartame, a popular artificial sweetener found in Diet Coke, chewing gum, yoghurt and other food products, is set to be declared a possible carcinogen next month by a World Health Organization arm.
Auditors uncovered “deficient” manufacturing equipment cleaning and storage controls during a visit last month to an Aurobindo Pharma Ltd. facility in Anakapalli, eastern India, according to a FDA report obtained by Bloomberg News through a Freedom of Information Act request.
Sanofi, one of the top global vaccine makers, has stated that the current mRNA technology used in COVID-19 vaccines is not effective against influenza. The company is working on a next-generation flu shot based on mRNA, which showed a strong immune response against A strains but not against less prevalent B strains. Sanofi aims to upgrade the technology to improve the immune response against B strains and enhance the durability of the vaccine at normal fridge temperatures.
The drug is used to treat a certain type of breast cancer. It works by slowing or stopping the growth of cancer cells. The product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad.
Indian manufacturer Marion Biotech used a toxic industrial-grade ingredient, propylene glycol (PG) which is a toxic material widely used in products such as detergents and antifreeze, instead of the pharmaceutical version in cough syrups that were said to have poisoned 19 children in Uzbekistan. The company purchased the ingredient from trader Maya Chemtech India, which did not have a license to sell pharmaceutical-grade materials. Marion also failed to test the ingredient before using it in the syrups.
The company, Marion Biotech, bought the ingredient - propylene glycol (PG) - from trader Maya Chemtech India, as reported by Reuters. But Maya did not have a licence to sell pharmaceutical-grade materials and "dealt in industrial-grade only," according to a source at the firm with knowledge of the Marion investigation.
A committee had been set up under the chairmanship of CK Kokate, former vice-chancellor of KLE University, Belgaum, to review the safety, efficacy and therapeutic justification of these drugs. The Drugs Technical Advisory Board (DTAB), India's top technical board on drugs, has now asked the panel for a report on their evaluation.
Khorakiwala-owned Humuza Consultants has pledged its entire 65.46% shares of Wockhardt with private lenders as of March 31, 2023, according to a stock exchange disclosure. The promoter intends to reduce the share pledge to 26% by the end of this fiscal year, the people cited above said.
"This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period," Gland Pharma stated. The observation issued is neither a repeated observation nor related to data integrity, it added.
In a significant and people-centric move, cashless treatment facilities will now be available to CGHS beneficiaries, both serving and pensioners, at AIIMS-New Delhi, PGIMER-Chandigarh and JIPMER-Puducherry.
As per the existing provisions under Schedule K of Drugs Rules, 1945, nicotine gum and lozenges containing up to 2mg of nicotine are exempted from sale licence and no prescription form a registered medical practitioner is needed for the retail sale of those products.
Boehringer Ingelheim on Monday said that the company has appointed Gagandeep Singh as Managing Director and Head of Human Pharma India, effective July 10, 2023. He will also join the Board of Boehringer Ingelheim India, the company said.
Niva Bupa is a JV between the Bupa Group and Fettle Tone LLP (an affiliate of True North Fund VI LLP), a leading Indian private equity firm. ET reported on June 23 that UK health insurer Bupa is in talks with True North to pick up an additional 15-20% stake in the insurance company at Rs 11,000-12,000 crore valuation. Bupa currently holds around 44% stake in the entity.
Gemcovac-OM, the booster vaccine for Omicron from Emcure's subsidiary Gennova, had recently received the nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorization (EUA). Individuals above 18 years and who have received either Covaxin or Covishield as primary vaccination can take it as a booster for active immunization for the prevention of COVID-19.
The union environment ministry has made the decision in consultation with the health ministry after inter-ministerial deliberations of more than a year. Allowing import of 'high-end and high-value medical equipment', not just by actual users and original equipment manufacturers but also by third-party traders, is expected to considerably open up the Indian market for these devices.
Dr Reddy's aims to roll out its trade generics across cities and towns in India, including rural areas. The company said it will work closely with its channel partners to ensure the availability of its products.
"There will be no bargain on quality," Health Minister Mansukh Mandaviya told media on the sidelines of the 8th Global Pharmaceutical Quality Summit 2023, held by industry body Indian Pharmaceutical Alliance.
India's Aurobindo Pharma has announced that its subsidiary Eugia Pharma Specialities has signed a voluntary sub-licensing agreement with Medicines Patent Pool to develop and market an anti-cancer drug- Nilotinib capsules. Nilotinib capsules are used for the treatment of chronic myeloid leukemia.
Researchers say diabetes is growing exponentially in prevalence outpacing most diseases globally. Structural racism and geographic inequity are accelerating this global crisis of diabetes, with rates of diabetes among minority ethnic groups in high-income countries, like the USA, 1.5 times higher than among their white counterparts and diabetes death rates in low- and middle-income countries (LMIC) double that in high-income countries.
Fortis Healthcare has signed definitive agreements with Kauvery Group of Hospitals for the sale of its hospital business operations in Vadapalani, Chennai, for Rs.152 crore ($20.4 million). The deal will be an all-cash transaction and is expected to conclude by the end of July 2023. The divestment enables Fortis to continue its portfolio rationalisation plan and to focus on deepening its presence in select clusters.
Experts and medical practitioners have demanded the inclusion of the progressive neurodegenerative disease - Amyotrophic lateral sclerosis (ALS) - in the national rare disease policy to enable patients to get affordable care and treatment. The demand came ahead of the Global ALS/MND (motor neurone disease) Awareness Day, was observed on Wednesday.
The Niti Aayog is spearheading the initiative and is holding discussions with multiple stakeholders to understand the potential and challenges that the country faces in the manufacturing of VVMs.
Founded in the 1990s by Late Shyamsunder Taparia, Jaiprakash Taparia and family, Pregna is a contraception devices maker in the global IUD (intrauterine devices) space with a growing portfolio of reproductive and women’s health products. Pregna has a presence in over 140 countries and is the largest IUD manufacturer in the world. The company is led by Mukul Taparia.
Pharmacy chain MedPlus Health Services has launched a discount scheme on up to 500 off-patent therapeutic and chronic medicines under its brand, with reductions of between 50% and 80%. The Hyderabad-based firm plans to extend discounts to more than 800 products over the next three months, including prescription drugs for the treatment of conditions such as hypertension, diabetes and kidney ailments.
"When we acquired the company in 2019, our expansion and goal was a region of about 45 centres by 2023. So we are ahead of our goal. And we are already 62," said Vishal Bali, executive chairman of Asia Healthcare Holdings (AHH), the healthcare platform's promoter.