Page 5 - Drug Makers In India

Drug regulatory reforms for improving quality

A strong drug regulation system is essential for India, as it not only supplies quality drugs to its own population but is responsible for meeting 20 per cent of the global demand

PLI scheme effect? Bulk drug imports from China slow, shows data

Experts say scheme to boost local manufacturing will take 5-7 years to show tangible results

Drug regulator CDSCO finds syrups made by Norris Medicines toxic: Report

The drug regulator for Gujarat state, where Norris is based, told Reuters that its factory had been closed

WHO's good manufacturing norms to be made compulsory for all drug firms

Only 2,000 of the 10,500 manufacturing units in the country have the World Health Organization's GMP certification

DCGI asks states to keep vigil on sale of falsified versions of 2 drugs

The Drugs Controller General of India (DCGI) has directed the drugs controllers of all states and Union territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda's cancer drug Adcetris (injection), following alerts issued by the World Health Organisation (WHO). In an advisory on September 5, the DCGI said the WHO has issued a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India. "These products are most often available at the patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation," the DCGI said in a communication to the

DCGI warns against use of pholcodine-containing cough syrups, cites risks

Regulator asks doctors to suggest an alternative to patients for treating their symptoms

World Drug Day 2023: Theme, History, Importance and More about drug abuse

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

Indiana Ophthalmics faces CDSCO probe; Pharmexcil may suspend membership

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

Contaminated drugs: USFDA uncovers failures in India's pharma factories

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

Pharma industry seeks graded introduction of trade margin rationalisation

TMR may be applied in phases, with the first one including drugs priced above Rs 100 or so

Drug sales stuck at pre-pandemic level, price rise shapes market growth

Respiratory medicines doing well as people recover from long-term effects of Covid-19

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