Regulator asks doctors to suggest an alternative to patients for treating their symptoms
The purpose of this World Drug Day 2023 campaign is to spread awareness of the significance of treating people using drugs with respect and compassion
CDSCO starts probe based in complaint by Sri Lanka that eyedrops made by the firm are linked to eye infections in more than 30 people
The $50 billion sector is under the spotlight after a number of recent scandals linked to smaller, privately-held Indian companies, including the deaths of dozens of children in Gambia and Uzbekistan
TMR may be applied in phases, with the first one including drugs priced above Rs 100 or so
Respiratory medicines doing well as people recover from long-term effects of Covid-19
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 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 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
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 ..
Marion's licence cancelled over no reply to show cause
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
Objective of drug regulation is to ensure safety, efficacy, and quality of drugs
The first nine patients that they will inject would be legally blind, as they have to prove safety first
The company has a total workforce of about 1500
Its local production ramp-up remains unhurried as demand for boosters reduces
Centre forms panel to analyse causal relation between deaths and cough syrups
Sales declining anyway and there is no need to ban because of alleged misuse, say experts
In December 2019 the decision was revised to allow sale of land to private entities as well through a competitive bidding process
Analysts expect double-digit growth for pharma major even if Q1 disappointed