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.
The US Food and Drug Administration's (USFDA)'s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars - lower-priced, near-replicas of complex biologic medicines - could significantly benefit Indian biotech companies.
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.
The government's move to cut GST on medicines and medical devices while exempting lifesaving drugs from the levy is a bold step that will bring direct relief to patients and families while significantly reducing financial strain on them, pharmaceuticals and healthcare industry players said on Thursday.
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.
Indian drugmakers supply 47 per cent of the generic medicine requirements in the US, and tariffs would have increased prices in the US domestic market for patients, who are already dealing with drug shortages.
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).
Industry insiders in India warn that any such move in the pharmaceutical sector could be counterproductive for the US as it may face increased drug shortages if tariffs are imposed on such imports.
'We have to be prepared for the larger disruption that is likely to take place.'
Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
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.
As the Drugs Controller General of India (DCGI) is set to crack down on companies to ensure compliance with printing QR codes on top-selling brands to curb counterfeiting, top pharma companies say they welcome the regulator's mandate and that they are on track. They also view it as a positive step to ensure patient safety. Sheetal Arora, CEO of Mankind Pharmaceuticals, which has already adopted QR codes in 20 of their products, stated: "We strongly advocate for mandatory implementation of barcodes and QR codes on medicines as this initiative will not only protect patients but also strengthen the integrity of our healthcare system by reducing circulation of counterfeit drugs."
The government has been stringent with pricing changes. Prices of 651 essential medicines came down from April 1, 2023 by 6.73 per cent with the government capping ceiling prices of these drugs.
For the consumer, there would be practically no impact on prices of essential medicines this year.
The top 300 pharmaceutical brands in the country will now bear a quick response (QR) code on their packaging to rein in spurious drugs and ensure better traceability.
The pharmaceutical and the consumer durables sectors, which depend on China for imports, have not been impacted yet due to unrest in China with people protesting against lockdowns. But the lockdown could have an impact on the supply of components used in consumer durables if it continues for the next fortnight. In the pharmaceutical industry, Indian players import 66-70 per cent of their bulk drug requirements from China.
The government should take measures to promote innovation and R&D while simplifying regulations for the sector in the upcoming Union Budget, as per pharmaceutical industry bodies. Outlining the wish list for the sector in the upcoming Union Budget, Indian Pharmaceutical Alliance (IPA) secretary general Sudarshan Jain said the domestic pharma industry is currently around $50 billion in size and aspires to grow to around $130 billion by 2030 and $450 billion by 2047. "To achieve this vision, the Union Budget 2023-2024 should help fuel innovation and R&D, which will set the pace for propelling the pharmaceutical industry forward," he told PTI.
Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets. While R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth of generics and injectable products, concerns such as price control and customs duties on medical equipment will continue to bother the healthcare industry in 2023. The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage, improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.
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.
When compared to the domestic sales of April 2019, the growth is around 37 per cent. However, compared to the previous month (March), the growth is 18.4 per cent.
'The Centre is planning to procure five million vials of Remdesivir ahead of the third wave. What's better is that this time, the government is paying us in advance,' said a senior executive of a Mumbai-based pharma player which makes Remdesivir. Sohini Das reports.
The government is targeting 1,200 technical collaborations between Japanese companies and Indian investors for over Rs 42,000 crore, 200 joint ventures with overseas investors for Rs 14,000 crore, and another Rs 14,000-crore investment from about 50 multinational companies.
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.
'I want to thank Prime Minister Modi of India for allowing us to have what we requested for the problem arose and he was terrific. We will remember it'
Cadila, Biocon developing rapid antibody testing kits; Eris, Mylan, Gland importing. There are two kinds of testing for the novel coronavirus - the real-time polymerase chain reaction test kit that uses throat or nasal swabs and provides results in a few hours, and the other is antibody-based rapid testing kit that use blood samples and provides results in a few minutes.
Exports of 13 APIs - including paracetamol, tinidazole, metronidazole, vitamin B1, vitamin B6, vitamin B12, acyclovir, progesterone - along with formulations made from these APIs, would be restricted.
Pharma companies gear up for the 'new normal' as they train and align their sales forces for a paradigm shift. GSK leads the charge with staggered return-to-work, others plans yoga sessions and health care webinars for salesperson's family.
Indian auto and pharma industries import several critical components and raw materials from China.
India lost its competitive advantage as China gave fiscal benefits to its local manufacturers. Besides, recent policy flip-flops have, however, dented India's image as the 'pharmacy of the world'.
The intention of the government is to cap prices of drugs that are essential and which the public widely uses.
The government said that "in exercise of extraordinary powers in public interest, conferred by paragraph 19 of the DPCO, 2013", the ceiling prices of 21 key formulations had been increased. These formulations include common medicines like BCG vaccines, penicillin, malaria and leprosy medicines (Dapsone), life-saving drugs like Furosemide (used to treat fluid build-up due to heart failure, liver scarring, or kidney disease), vitamin C, some common antibiotics, and anti-allergy medicines.
In the concluding article of a six-part series, Business Standard visits Ludhiana, one of the largest industrial towns in Punjab, to assess the effect of demonetisation.
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