Drug Makers In India

DCGI asks drug manufacturers not to use propylene glycol by Delhi firm

India's drug regulator has directed drug manufacturers not to use propylene glycol supplied by a Delhi-based company which provided the ingredient to Marion Biotech, whose cough syrups were alleged to have led to the deaths of children in Uzbekistan. Maya Chemtech India Pvt. Ltd. supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator. Three employees of Marion Biotech were arrested on charges of manufacture and sale of adulterated drugs. Also, the drugs inspector from the Central Drugs Standard Control Organisation (CDSCO) North Zone last week issued a notice to the pharmaceutical firm asking it to stop the sale and distribution of the drug concerned, stating that the sample was found to be "not of standard quality". Uzbekistan alleged in December last year that several children died after consuming Marion Biotech's cough syrups, which it claimed were contaminated with unacceptable amounts of ethyl

Analysts turn cautious on Cipla as US FDA action delays key US launches

Analysts believe that some of the recent observations from the US FDA are critical in nature and could lead to a potential Official Action Indicated (OAI) classification for the Indore plant

India needs regulatory data protection for drug research: Novartis CEO

India should have a regulatory data protection system in place to attract fundamental drug research from major pharmaceutical companies in the world, Novartis Chief Executive Officer Vasant Narasimhan said on Friday here. Speaking to reporters on the sidelines of the life sciences conclave 'BioAsia 2023' being held here, Narasimhan said great work has been done to streamline Intellectual Property (IP) issues which can be further improved. "I think the next step is when you think about how we generate data and how protected that is in regulatory filings. India does not have regulatory data protection," he said replying to a query. If one looks at any place in the world where there is significant fundamental drug research happening from multinational firms, there is regulatory data protection, including China, Narasimhan further said. The Novartis CEO added that getting approvals for clinical trials used to be very difficult in India earlier. However, with the new policy, the process

Govt to organise 'Chintan Shivir' with focus on drug quality regulation

New Delhi [India], February 24 (ANI): Union Health and family welfare Minister Dr Mansukh Mandaviya will chair a two-day 'Chintan Shivir' at Telangana's Hyderabad with a focus on Drug Quality Regulation and Enforcement."Eminent speakers along with Domain experts from government, industry fora, startups, and academia will be participating," official sources told ANI.The Chintan Shivir will be held for two days from February 26- 27, 2023 at Shanti Vanam in Hyderabad.Dr Bharati Pravin Pawar, Minister of State for Health and Family Welfare, Dr Bhagwant Khuba, Minister of State for Chemicals & Fertilizers along with Dr V K Paul, Member (Health) NITI Aayog will attend the meeting. Senior officials including Union Secretary (Health), Secretary (AYUSH), Secretary (Pharmaceuticals), DGHS along with representatives from National Health Authority, NPPA, CDSCO, NIB, Indian Pharmacopoeia Commission, NIPERs, State functionaries and officials including ACS/Principal Secretary will be present ..

Cough syrup deaths: Marion's licence suspended over no reply to show cause

Marion's licence cancelled over no reply to show cause

Bitter medicine for pharma regulation

The Gambian tragedy has raised uncomfortable questions about drug regulation in India. The Truth Pill is a depressing but eye-opening reality check of the regulatory landscape

CDSCO, states begin joint checks of drug-making units across India

Objective of drug regulation is to ensure safety, efficacy, and quality of drugs

Eyestem to start first trial in India to treat age-related blindness

The first nine patients that they will inject would be legally blind, as they have to prove safety first

Drug, medical services firm PharmEasy may lay off hundreds of employees

The company has a total workforce of about 1500

Bharat Bio looks for partners to manufacture, distribute iNCOVACC globally

Its local production ramp-up remains unhurried as demand for boosters reduces

Drug regulator halts production at Maiden Pharma's Sonipat unit

Centre forms panel to analyse causal relation between deaths and cough syrups

Pharma industry says taking steps to check misuse of codeine drugs

Sales declining anyway and there is no need to ban because of alleged misuse, say experts

Land parcels of pharma PSUs find no takers, but momentum likely in few mths

In December 2019 the decision was revised to allow sale of land to private entities as well through a competitive bidding process

Core brands, new launches to help Abbott India stock outperform: Analysts

Analysts expect double-digit growth for pharma major even if Q1 disappointed

Largest Ibuprofen API maker eyes double revenue in next four years

As part of de-risking their business, they have started reducing the share of ibuprofen in their overall turnover, and add more popular products to the portfolio

Streamlining trade margins on drugs priced Rs 100 and above likely

Drugs for ailments like chronic kidney disease, some high end antibiotics, anti-virals (anti-infectives), as well as some cancer drugs are likely to be brought under trade margin rationalization first

Ethical Code to keep doctor, drugmaker nexus at bay not mandatory yet

The recent controversy following income tax raids on Micro Labs, makers of popular paracetamol brand Dolo, is likely to make things move in making the UCPMP

Bharat Biotech says Phase 3 trial over, intranasal vaccine 'safe'

The Hyderabad-based company claimed that BBV154 is proven to be safe, well-tolerated and immunogenic in the subjects under controlled clinical trials

Glaxosmithkline Pharma Q1 consolidated net profit up 8% at Rs 116 crore

Drug manufacturers GlaxoSmithKline on Monday said its consolidated net profit increased to Rs 116 crore in the first quarter. Shares of the company closed at Rs 1,726.20 on BSE, said reports

Natl Pharma Pricing Authority fixes retail prices of 84 drug formulations

Drug pricing regulator NPPA has fixed the retail prices for 84 drug formulations, including those used for treatment of diabetes, headache and high blood pressure. The National Pharmaceutical Pricing Authority (NPPA) has also fixed the prices of formulations indicated to reduce increased cholesterol and triglycerides levels, among others. In exercise of the powers conferred by the Drugs (Prices Control) Order, 2013, the NPPA has fixed the retail prices of the medications, the regulator said in a notification. As per the order, a single tablet of Voglibose and (SR) Metformin Hydrochloride will cost Rs 10.47, excluding GST. Similarly, the price of Paracetamol and Caffeine has been fixed at Rs 2.88 per tablet. Besides, the price of one Rosuvastatin Aspirin and Clopidogrel capsule has been fixed at Rs 13.91. In a separate notification, NPPA said it has extended the revised ceiling price of liquid medical oxygen and oxygen inhalation (medicinal gas) till September 30 this year. The NP