The FDA has stepped up its efforts to ensure drug safety in recent months.
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.
President Donald Trump delayed tariffs on Mexico and Canada for a short-term period for certain products before the 'big one' from April 2.
The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.
Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices. In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI).
Here is a list of items set to become cheaper and costlier.
Gold, silver and other precious metals along with imported mobile phones, certain cancer drugs and medical devices are set to become cheaper with Finance Minister Nirmala Sitharaman announcing cuts in customs duty in the Union Budget 2024-25.
The heightened global uncertainty due to the US "reciprocal tariffs" on India may cause near-term corrections and market turbulence, but the long-term outlook remains constructive, market experts said on Thursday. The US has announced 27 per cent reciprocal tariffs on India, citing high import duties imposed by New Delhi on American goods.
Big pharma companies, however, said while it was true that formulation players would not rush to buy raw material, they could not afford losing customers.
'Kamal has surfed and navigated a lot of tidal waves, manoeuvring the peaks and troughs, combining rare intelligence and commonly available intuitions to overcome unimaginable crises all his life.' 'There is no looking back at the past, for his only motto has been 'Tomorrow belongs to us'!'
An Indian official team is likely to visit Washington next week to iron out differences on certain issues before formally launching negotiations for the proposed India-US bilateral trade agreement (BTA), an official said. The visit, which comes within weeks of a high-level US team visiting India, indicates that the talks for the BTA are gaining momentum.
A probe has been initiated by India's drug regulator after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
The Department of Social Justice and Empowerment has received Rs 13,611 crore in the Union Budget announced on Saturday, while the allocation for disability welfare now stands at Rs 1,275 crore.
The most striking features of this Budget was its focus on simplification and improving the ease of doing business in India, asserts Kaku Nakhate.
The API of Paracetamol, a fever and pain medication, has grown 25 per cent from Rs 450-480 per kg in December 2020 to Rs 580-600 per kg in April. When compared to the pre-Covid prices of December 2019, the surge is much steeper -- around 140 per cent, reports Sohini Das.
Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing. As per the US Food and Drug Administration's Enforcement Report, the US-based arm of Sun Pharmaceutical Industries is recalling lots of Diltiazem Hydrochloride extended-release capsules which are used to treat angina, high blood pressure and some types of irregular heartbeats.
The official said there are both challenges and opportunities for India as many of its competitor countries in exports, such as China Vietnam, Bangladesh, Cambodia and Thailand, face higher duties.
Pharma Link, a joint venture of leading pharmaceutical support service provider Interpharma Asia-Pacific
market, was today seized from an illegal drug manufacturing unit in Jalgaon district in north Maharashtra and six persons were arrested, Directorate of Revenue Intelligence officials said.
The minister said that his ministry will clear its stance on Patanjali's ayurvedic drugs after reviewing the report sent by it.
Reliance Life Sciences is planning to invest at least Rs 1,000 crore (Rs 10 billion) to set up hospitals in the country's metros and dispensaries in small towns.
'No retaliatory tariffs now. You can retaliate after a few months.' 'Today, there is no need to retaliate because it is a question of long term benefits.'
The products worth Rs 5,000 crore have been banned for manufacture, distribution and sale with immediate effect causing hardship to manufacturers and patients.
The Budget has given signals that India is sensitive to the US needs and willing to walk the extra mile, but if need be, we should respond in equal measure as a sovereign nation, notes Ajay Srivastava.
They said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by the WHO, the committee will advise and recommend further course of action to the Drugs Controller General of India (DCGI).
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
European regulators have estimated that consumers are paying up to 20 per cent more for medicines in some cases.
Here is a list of Q & As to explain these issues and implications of the US move.
The commerce ministry is working on different scenarios to assess the possible fallout of reciprocal tariffs to be imposed by the US administration on April 2 on its key trading partners including India, sources said. US President Donald Trump has said that April 2 will be 'Liberation Day' as he plans to announce tariffs or import duties to bring down America's trade deficit, and promote the country's manufacturing.
Mandatory prescription of generic names is not a complete solution. Rather, in the absence of a range of approaches, it could mean passing the choice of selecting a drug from a doctor to a pharmacist, says Chandrakant Lahariya.
United States President Donald Trump on Sunday criticised the trade deficits that the US has with Canada, Mexico, China, and argued that America should no longer 'subsidise' other countries, and urged businesses to manufacture domestically to avoid tariffs.
Besides opposing the suspension of three medicines, the sector has also questioned the process adopted by the government.
Move follows a spate of international regulatory enforcements on Indian drug firms.
'Growth for some companies has been hard to come by and this is a smart way to get there.'
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
The Budget 2025-26 meets the expectations of fiscal consolidation, maintaining capital expenditure, and boosting consumption through tax cuts.
A woman died and four others were critical after the delivery of babies at a state-run hospital in West Bengal's Paschim Medinipur district allegedly due to the administration of expired intravenous fluid, prompting the health department to order an investigation, officials said on Saturday.
"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.
