In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
The voluntary move comes a little more than a year after the Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing, had asked the drug makers to withdraw the 'combination drugs' as they are 'unnecessary' and may pose health hazards. The Drugs Controller General of India had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007.
Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government's March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.
The reasons are too private to be discussed at a round table, listed out during a seminar, or uncovered in an academic course. A proud but insomniac connoisseur murmuring in his sleep may do a better job of explaining the phenomenon than an expert on a podium. Sreehari Nair airs his thoughts.
According to DMK, the voters are already consolidated on ideological lines, hence the impact of anti-incumbency, whether against the BJP Centre or the DMK state may not be too much, notes N Sathiya Moorthy.
It is estimated that over 95 per cent of drugs being produced in India are off-patent and would not be affected by introduction of product patent,
While the responses of the candidates were predictable, depending on which side they belonged to, an interesting point slipped through when Rahul Shewale cited the Dharavi Redevelopment Project as a scheme that would add to Mumbai's importance. No big infrastructural project in Mumbai, he said, could be successful without the Centre's nod.
In a landmark judgment that has the potential to change the direction of India's pharmaceutical business, the apex court said on Monday that the drug failed to qualify for a patent according to Indian law.
Povidone iodine ointment and solutions are available in the market under various popular brands such as Betadine and Wokadine.
Olympic sprint champion Usain Bolt said on Saturday that controversy over Jamaica's anti-doping programme is scaring off potential sponsors and costing him money.
The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
Kopran Ltd launched two new cardiovascular drugs - Caditone (Carvedilol) for the treatment of hypertension and congestive cardiac failure and Zeter (Clopidogrel) to prevent blockage of artery by clot formation (thrombosis).
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
Alkem, the largest manufacturer of Fructo-Oligo Saccharides, which helps the growth of good probiotic bacteria, is planning to roll out more products in the national and global markets, said Sharad.
The Enforcement Directorate has managed to sniff out over Rs 9,000 crore as suspected haul from money laundering in a decade, but it has yet to link those against anyone successfully in a court.
The panel of representatives from various ministries and chaired by B K Singh, director, department of pharmaceuticals, has suggested the government negotiate prices of patented medicines based on reference prices of such drugs in other countries such as Britain, Canada, France, Australia and New Zealand.
Abhishek Chaubey talks about Udta Punjab, his actors and how the drug-themed film happened.
Argentina has assured India that it will resolve the issue of restrictions on import of Indian drugs to the Latin American country.
Two Delhi High Court judges have ignored statutory regulations and are seeking to mandate a link between drug regulation and patents where none exists in law, says Latha Jishnu.
Drug maker Sun Pharmaceutical Industries on Monday said it has commercially launched generic Ethyol, used in the treatment of cancer. Ethyol is the generic version of Medimmune's Ethyol amifostine injection, used for treating cancer, Sun Pharma informed the Bombay Stock Exchange, adding that the drug has an annual sales of $80 million in the US.
Sticking to its recommendations of de-branding essential drugs and a single regulatory authority for drug pricing, the Pronab Sen Task Force on Tuesday submitted its final report to Chemical and Fertilisers Minister Ramvilas Paswan.
The pharmaceuticals sector is expected to post a revenue growth of around 13.5 per cent and a net profit growth of 30.3 per cent for the third quarter of 2023-24 (FY24), riding on the approval for niche drugs in the US market, fall in raw material prices and correction in shipping rates. In the healthcare segment, hospitals are expected to post revenue growth of 13 per cent during the coverage, while net profit growth would be around 37 per cent, ICICI Securities said in a note. However, the performance may not be comparable on a sequential basis due to the offset of the festive season in Q3FY24, the analysts noted.
One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.
2.3 million people are opioid-dependent. 860,000 people are opioid users. 123,000 people are heroin-dependent.
China has formally apologised to Nigeria for alleged export of fake drugs including some labelled as 'Made in India' by some Chinese firms to the country and assured to take punitive action against those involved in the scandal.
Unregistered sources of consignment raise quality questions.
Now, the companies need to get National Pharmaceutical Pricing Authority's nod for changing medicine composition. If they flout norms, government will take penal action.
Multinational drug manufacturers such as Pfizer and DSM are increasingly getting into contract manufacturing alliances with emerging bulk drug makers in the country, bypassing established players such as Ranbaxy and Dr Reddy's.
To ensure equal access to health care, the government must consider it in a holistic manner and improve all parameters.
Days after medical representatives said their employers were flouting the government's drug-pricing norms, the pharmaceutical industry has decided to clip their wings. These companies want them to be no longer recognised as "workmen," a classification that gives them the right to form trade unions.
India's status as the pharmacy of the world is at stake.
358 of 413 drug patent applications for the disease in India are from top multinationals. An analysis of pharma patent applications pending with the patent office by the group, which did not wish to be identified, has put the number of cancer drug patent applications at 413. Of these, 358 came from top multinationals like Novartis, Aventis, Bristol Myers Squibb, Pfizer, Boehringer, Roche and Abbot.
Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.
The 550,000 unorganised drug traders in the country are readying to take on the entry of corporate houses like Anil Dhirubhai Ambani Group
