Abbott will exclusively distribute and market Extensior in the country, becoming the second company to secure sole distribution rights for Novo's semaglutide portfolio in India, after Emcure Pharma.
The European Union's (EU's) offer to slash tariffs on 97.5 per cent of Indian chemical exports to zero is set to give India's pharmaceutical and medical device firms preferential access to the European markets.
All doctors must prescribe generic drugs, failing which they will be penalised and even their license to practice may also be suspended for a period, according to the new regulations issued by the National Medical Commission (NMC).
After a year of modest returns, equity investors may anticipate gains of 10-15 per cent in Samvat 2082, which began on October 21. Although valuations have moderated from their peaks a year earlier, they remain above long-term averages, potentially limiting sharp upsides.
Indian Pharmaceutical Alliance (IPA) on Friday said US President Donald Trump's move to impose 100 per cent import tariffs on pharmaceutical drugs from October 1 will impact only patented and branded products, not generic medicines.
If pharmaceutical exports from India to the US come under a 25 per cent tariff bracket, the impact on earnings before interest, tax, depreciation and amortisation (Ebitda) could be around 5 per cent, felt analysts. This is after assuming that about 75 per cent of the tariff would be passed on.
India has not accepted the demand of the UK for inclusion of a 'data exclusivity' provision in the free trade agreement, announced on May 6, in a bid to protect the interests of the domestic generic drugs industry, an official said. During the negotiations, the UK had asked to include this provision in the trade pact.
Members of the IMA and IPA had met Mansukh Mandaviya on Monday and expressed their concerns over the regulations.
India's pharmaceuticals and medical devices industries are still hopeful that trade negotiations with the US could cut a fairer deal for both sides, after President Donald Trump announced a 25 per cent tariff rate on India on a social networking platform without divulging the finer details.
US accounts for a large part of revenue for top Indian pharma companies like Gland Pharma (54 percent), Dr Reddy's (53 per cent), and Aurobindo Pharma (48 per cent).
The restructuring of tariffs by the US has led to a shift in the list of key product suppliers to the American market, with India emerging as one of the beneficiaries at the expense of China and Canada, an official said on Monday. As per an analysis, India's share in the USA's electronics exports has increased to 7.2 per cent to 3.5 per cent year-on-year in May, while China's share dipped to 11 per cent from 22 per cent during the same period.
The change in labelling, which is seen as a part of government's effort to push generic drugs, will come into effect from September 13.
Regulator says fee would enable it to quicken approval process.
The Indian pharmaceutical industry is likely to benefit from a major wave of patent expiries in the US, as small-molecule drugs worth $63.7 billion are expected to go off-patent between 2025-29, a 65 per cent rise over the previous five years, according to a report by Antique stock broking limited.
A fresh US executive order (EO) which seeks to bring down prices of prescription drugs in the country by up to 90 per cent -- on par with other developed nations -- will affect innovator companies, while sparing the Indian generic drug makers in the short term. US President Donald Trump signed the EO on Monday, directing the US Trade Representative and the Secretary of Commerce to act against foreign countries that "purposefully and unfairly undercut market prices", driving price hikes in the US.
The non-branded generic drugs (sold under chemical names such as cetrizene, omeprazole and nimusulide), which constitute about 8 per cent of the Rs 30,000 crore (Rs 300 billion) Indian pharmaceutical market, is currently not subjected to any such margin cap and according to a study done by the department some of them such are even sold at a margin as high as 1,000 per cent in the market.
Bihar Chief Minister Nitish Kumar on Monday said that Bollywood actor Aamir Khan is welcome in the state to create awareness and popularise generic drugs among people.
US President Donald Trump's plan to sign an executive order to cut prescription drug prices by 30-80 per cent could lead to a global price adjustment with pharma firms pushing lower-cost countries like India to raise prices, according to the economic think tank GTRI. The US move could push prices in lower-cost countries like India as manufacturers would seek to recover losses and R&D costs from these nations.
Due to the massive short supply of Paxlovid, demand for Indian generic versions has gone up through Chinese e-commerce platforms.
Experts believe the move will have little impact given limited production of generic drugs and authority of doctors in prescribing medicines.
The Wall Street Journal has reported that the SEC has contacted many investment banks whose analysts cover generic drug-maker Mylan, asking about a meeting the company hosted last September with those analysts and a group of investors.
This move could cost $299 million a year for Indian pharma players.
Pharmexcil had recently taken a 25-member delegation to Iran in order to promote pharma trade with the Western Asia nation.
The increasing number of generic players tapping the US market for known molecules has resulted in pricing pressures and lean margins.
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.
The US-based Dawn Alliance group is planning to set up a United States Food and Drug Administration-approved generic drug manufacturing facility in India.
The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
The drug that it would supply is called Olanzapine, used to treat schizophrenia and bipolar disorder.
They seek to profit from big-selling drugs going off-patent this year in the lucrative market.
S&P Global Ratings on Wednesday said the impact of the US reciprocal tariff will be limited on India as the economy is domestically oriented with less reliance on exports. YeeFarn Phua, Director, Sovereigns and International Public Finance Ratings, Asia-Pacific S&P Global also said India will clock a 6.7-6.8 per cent GDP growth over the next two years.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
India's healthcare and pharmaceutical sectors raised Rs 14,811 crore through initial public offerings (IPOs) in 2024, the largest since 2019, driven by strong domestic demand amid expanding global opportunities. According to data, key contributors to the record fundraising included Sai Life Sciences (Rs 3,043 crore), IKS Health (Rs 2,498 crore), and Sagility India (Rs 2,107 crore).
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
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.
'Whichever company offers better incentives, the chemist would prefer it.'
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
The Planning Commission's working group on drugs and food for the 12th Five-Year Plan estimated that the country's public health sector caters to only 22 per cent of the population.
Germany's drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by India's pharmaceutical research company GVK Biosciences were "insufficient".
Ranbaxy Laboratories Ltd, India's top drugmaker by sales, said it expected to get US approvals for a paediatric dosage of its generic version of Augmentin, GlaxoSmithKline's blockbuster antibiotic, within a month.\n\n\n\n
Trade generic drugs (medicines that are sold directly through distributors) are fast becoming a key segment for domestic pharma firms as volume growth slows in the overall market. Big companies like Cipla and Alkem have a significant presence in the segment but recently, players like Torrent Pharmaceuticals and Dr Reddy's Laboratories (DRL) have also entered this market. What is driving big pharma's focus on trade generics? The volume growth in the Indian Pharma Market (IPM) has come down from 5.6 per cent in FY16 to 0.1 per cent in FY23.
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