The patent department made this declaration on August 16 after Novartis had failed to respond to its queries within the prescribed time.
This move could cost $299 million a year for Indian pharma players.
Move follows a spate of international regulatory enforcements on Indian drug firms.
After the first quarter was washed out, exporters are now keeping their fingers crossed over a turnaround in outbound shipments to at least North America from September onwards. This comes even as other key destinations such as Europe may take longer to revive in FY24. Slowdown in key economies, as well as geopolitical tensions resulted in sluggish demand for Indian goods.
Even as the domestic pharmaceutical industry is exploring new markets in Latin America and the Commonwealth of Independent States, exports to countries in Africa are declining.
'If someone were to ask you if you want to die tomorrow, no matter what problems you are grappling with, you would be hesitant, right?'
Wockhardt said it is launching the product immediately in the US market.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
The profit margins of multinational companies importing medicines into India have been hit with the National Pharmaceutical Pricing Authority starting strict scrutiny of price approval applications for imported products.
Intelligence Bureau officers say the problem lies with the government treating narcotics and terrorism as two separate problems, with different law-enforcing agencies for each, and this ends up in defeating the purpose. Vicky Nanjappa reports.
The government has permitted Teva Pharmaceuticals of Israel and its Dutch subsidiary to together invest $8 million to acquire Regent Drugs from J&K Drugs and Pharmaceuticals.\n\n\n\n
Ranbaxy Laboratories on Thursday launched a generic version of Prasugrel, used in treating heart diseases, from Daiichi Sankyo portfolio in India as part of strategy to launch drugs from the parent company's stable.
Sixty firms' business worth Rs 1,000 crore at stake.
Court has barred generic drugmaker Cipla Ltd from making or selling a cheaper copy of Novartis AG's respiratory drug Onbrez domestically.
Pfizer, the world's largest drug company, and Wyeth have sued Daiichi Sankyo-owned Ranbaxy Laboratories in a US court for infringing the patent rights of Wyeth's drug, Rapamune.
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
The fees for facility inspection of foreign companies have been reduced
Former Narcotics Control Bureau (NCB) zonal director Sameer Wankhede is trying to show the alleged messages exchanged with film superstar Shah Rukh Khan as certificate of integrity, the Central Bureau of Investigation (CBI) told the Bombay high court on Monday during a hearing of a petition of the official who is accused of seeking Rs 25 crore as bribe from the actor for not implicating his son Aryan in the Cordelia cruise 'drug bust' case.
Import alert on unit-6 facility might be lifted by FDA by Sept.
A new report says laws crimp Medicare's ability to control costs on cancer, leading to a 267% increase in drug spending over seven years
The South African government and large pharmaceutical companies are in combat mode regarding the proposed national policy on intellectual property that hopes to improve access to medicines for the poorer sections of the population.
Pharma major Wockhardt on Wednesday said it has launched Tamsulosin capsules, indicated for problem of prostate enlargement, in the US market on the day one of the expiry of patent covering the drug.
Swiss pharmaceutical major Hoffmann-La Roche's patents rights over Hepatitis C drug Pegasys has been challenged by public interest groups at the Indian Patent Office.
The court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.
The Indian drug industry's dream of coming out with an own new chemical entity or an originally researched new drug has received a big boost. Balaglitazone, the diabetic drug molecule being developed by Dr Reddy's Laboratories, has showed encouraging results in the final lap of human clinical trials.
A shocking revelation that banking giants HSBC and Standard Chartered are suspected to have laundered money for drug cartels has prompted an in-depth inquiry by Indian investigation agencies.
NPPA suggests expanding the list of essential medicines whose prices are controlled
European regulators have estimated that consumers are paying up to 20 per cent more for medicines in some cases.
The government is creating a database of traditional Indian drugs aimed at preventing wrongful patenting of drugs, including medicinal plants. This is being done to prevent misappropriation of knowledge about our ancient heritage and wrongful patenting of drugs," Minister of State for Health and Family Welfare Panabaaka Lakshmi said. Speaking at the International Herbal Summit and Expo, Lakshmi said the efficacy of medicinal plants in India needs to be documented.
We don't expect any big changes in on excise duty and custom duty rates, except in life saving drugs.
A public interest litigation was filed in the Delhi high court on Monday against permission to exchange Rs 2000 banknotes without obtaining any requisition slip and identity proof.
The Department of Pharmaceuticals has submitted a freight subsidy scheme for exporters to the Commerce Ministry so that they could take alternate routes and avoid transit through Europe, which is a shorter route with better connectivity.
commercial airlines and air navigation service providers have to carry out random drug tests on at least 10 per cent of their flight crew and air traffic controllers every year.
The headline for corporate profit growth has been very encouraging in the July-September quarter (Q2) of 2023-24 (FY24), with the combined net profit of listed companies up by 38 per cent year-on-year. However, the earnings distribution has been very lopsided, with most of the growth coming from public-sector oil-marketing companies (OMCs), banks, non-bank lenders, automobile (auto) companies, and cement producers. By comparison, companies from information technology services, fast-moving consumer goods (FMCG), retail, and consumer durables were disappointed, experiencing a sharp slowdown in net sales growth and a relatively muted increase in reported net profit.
