A critical drug developed on a DRDO technology for radiological and nuclear emergencies has received approval from the Drugs Controller General of India (DCGI), the defence ministry said on Tuesday.
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).
United States-based drug major Forest Laboratories has sued three Indian pharmaceutical companies -- Orchid Chemicals and Pharmaceuticals, Lupin and Wockhardt -- along with four other manufacturers for coming up with imitations of patented drugs in the US.
Due to the massive short supply of Paxlovid, demand for Indian generic versions has gone up through Chinese e-commerce platforms.
Drug sale volumes are almost stuck at pre-pandemic levels but price growth has improved value, data from market research agency Pharmarack AWACS showed. The Indian pharmaceutical market's (IPM) volumes in April 2023 grew by 0.21 per cent when compared to April 2019. Key therapy areas like cardiac, anti-diabetic and vitamins recorded negative volume or consumption growth, while respiratory, anti-infectives, and pain and analgesics had positive growth from April 2019 to April this year.
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.
According to the Department of Pharmaceuticals' annual report for 2024-25, India imported medical devices worth $8.1 billion, while exports stood at $3.7 billion in the financial year 2023-24 (FY24)
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.
The Centre is considering a proposal on increasing coverage under the Ayushman Bharat scheme to Rs 10 lakh from the current Rs 5 lakh.
'Growth for some companies has been hard to come by and this is a smart way to get there.'
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
Industry associations and companies in the United States, including the US Chamber of Commerce, Coalition of Services Industries and the iconic bike company Harley Davidson have called on the Donald Trump dispensation to push India to reduce tariffs, non-tariffs, and regulatory barriers to boost American exports.
Here is a list of items set to become cheaper and costlier.
The government has decided to hold off introducing the production-linked incentive (PLI) scheme for additional sectors until it verifies the efficacy of existing initiatives. Top government officials have received mixed feedback on the scheme, including insights from the Economic Advisory Council to the Prime Minister, people aware of the matter said. "There are no new PLI schemes in the offing.
The government is expediting visa-related issues to bring technicians to India from any country, not just China, as and when required, to ensure the smooth implementation of the flagship production-linked incentive (PLI) scheme aimed at boosting domestic manufacturing. "If those under the PLI scheme need to get their equipment installed, we try to expedite the ability to get technicians into India from any country, whichever it may be," Union Commerce and Industry Minister Piyush Goyal told Business Standard in an interview.
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.
Anti-infectives like Ivermectin, Mupirocin and Meropenem have also been added to the list, taking the total drugs under it to 384.
The total incentive outgo under the ambitious production-linked incentive (PLI) scheme is estimated to be less than Rs. 40,000 crore by the fiscal year 2024-25 (FY25), when it completes the fourth year of implementation, according to the government's internal estimates. This means only a fourth of the allocated Rs 1.97 trillion is expected to be utilised by the end of FY24, indicating that not all the 14 PLI schemes would have taken off fully. While three of the 14 schemes - large-scale electronics manufacturing, bulk drugs, and medical devices - were introduced in 2020, the remaining were launched the following year.
Dabba Cartel's reluctant black comedy in the body of a crime thriller starts out interestingly enough to accomplish its Narcos: Thane aspirations, notes Sukanya Verma.
The inspection at Marion Biotech started at around 12 pm and continued for over 10 hours during which six more samples of the syrup were taken, they said.
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.
There is a need to incentivise R&D investments, offer corporate tax concessions and establish an effective intellectual property rights regime in order to push the growth of domestic pharmaceutical industry, as per the industry bodies. Outlining the sector's wish list for the upcoming Union Budget, Organisation of Pharmaceutical Producers of India (OPPI) Director General Anil Matai urged the government to explore methods to incentivise R&D investments, such as deductions on R&D expenses, research-linked incentives for MNCs, and corporate tax concessions.
Here is a list of Q & As to explain these issues and implications of the US move.
Do we have enough trained oncologists and medical professionals in India to man these over 4,500 beds in the public sector?
The Budget 2025-26 meets the expectations of fiscal consolidation, maintaining capital expenditure, and boosting consumption through tax cuts.
The Union health ministry on Friday said license has been given to five more manufacturers for production of Amphotericin-B, used in the treatment of black fungus, and they will start producing 1,11,000 vials of the drug per month from July.
Rising penetration of trade generic medicines is eating into the value growth of the domestic pharmaceutical market, showed a recent analysis. According to a Kotak Institutional Equities analysis, 70-110 basis points (bps) annual dent is expected from trade generics and Jan Aushadhi on Indian Pharma Market (IPM) growth at least until FY27-28 (see chart). Trade generic medicines are those that are not pushed into the market through doctor promotions.
After registering a net profit of Rs 25.1 crore in Q3FY25 and consolidated revenues growing by 7 per cent on a like-for-like basis, Siddharth Mittal, chief executive officer (CEO) and managing director, Biocon, told Sohini Das/Business Standard in a virtual interaction that local manufacturing in the US is a trade off between cost and qualifying to do business there.
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.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
Research and development (R&D) spending by BSE 100 companies has grown steadily, rising from 0.89 per cent of revenue in FY20 to 1.32 per cent in FY24, averaging around 1 per cent over the period in-between, according to data compiled from Bloomberg and company annual reports. Also, these companies more than doubled their R&D spending in absolute terms over these five years: From Rs 25,041 crore to Rs 63,072 crore. While this reflects a prioritisation of innovation, corporate R&D investment remains relatively conservative.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
Oral paracetamol and another cough medicine manufactured by companies based in Mumbai and Punjab were found to be "sub-standard or found to be containing toxins", reports Sohini Das.
The National Medical Commission in the Professional Conduct Regulations also bar doctors from endorsing any drug brand, medicine or equipment, or advertise them.
Indian Council of Medical Research had also recommended the use of hydroxychloroquine for treating healthcare workers handling suspected or confirmed coronavirus cases and also the asymptomatic household contacts of the lab-confirmed cases.
Around six weeks ago, Sun Pharmaceutical Industries, India's largest drugmaker, suffered a setback, which led to a selloff in the share. The US District Court of New Jersey granted Incyte's request for a preliminary injunction against Sun Pharma's launch of Leqselvi, a drug that treats alopecia.
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
'It is not just the US and European opportunity, but it is a huge global opportunity.'
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.
Riteish Deshmukh makes this medical drama watchable! exclaims Namrata Thakker.
