Indian pharmaceutical companies are heavily dependent on China to source fermentation-based active pharmaceutical ingredients and intermediates to manufacture these medicines, but the coronavirus outbreak there has disrupted the supply.
State Ayurved Department's licence officer Y S Rawat said the notice is being issued to the firm to explain from where it got the permission to launch a 'corona kit' as a cure from the virus.
After reports of contamination in cough syrups sent from the country, India is considering a system to test them before exporting. It is learnt that the Central Drugs Standard Control Organisation (CDSCO) has sent a proposal to the Union health ministry on this. The idea is to test the medicines at government labs before exporting.
The finance ministry is resisting pressure from other departments to cap foreign ownership of domestic drugmakers, fearing such a move would discourage potential investors, a senior ministry source said.
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
This move is expected to benefit 22 lakh cancer patients in the country.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
Gujarat has around 3,000 licensees for allopathic drug manufacturing, apart from around seven homeopathic licensees, 500 ayuvedic and 600-700 cosmetics licensees
The state govt has raised drug procurement budget.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
Large pharmaceutical firms feel that if the quality parameters and assurance levels are brought up to the level of branded generics, then Jan Aushadhi medicines would find it difficult to retain their affordability.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
He said a petition has been filed before the Supreme Court, seeking an independent probe by a special investigation team into the alleged nexus between political parties and companies for corruption through electoral bonds.
Wockhardt said, the drug regulator suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg
The Delhi high court had earlier allowed Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination that is banned.
Shahrukh Khan is one of India's most loved "human brands", and while the drug controversy may have paused his endorsement engagements, it has not dented the superstar's popularity among corporate, as per industry experts. Right after the controversy around his son's arrest in an alleged drug case broke out, many companies halted ads featuring King Khan. Many of them are now back on screens.
So far this year, bankers have earned Rs 1,226 crore for handling 45 IPOs, which together mobilised Rs 48,363 crore.
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
Firms could lose licence if products not launched within 6 months of approval.
In her bail application filed in the HC on Tuesday, Chakraborty said she is just 28 years of age, and besides the probe by the NCB, she has been subjected to three more investigations by police and central agencies, and a "simultaneous media trial".
Gland Pharma beat muted expectations for Q2FY25. There was increased Ebitda (Earnings before interest, taxes, depreciation and amortisation) loss at Cenexi, the CRAM subsidiary. However, overall Ebitda margin was better than expectations at 21.1 per cent. But given two years of earnings decline in FY23 and FY24, the business may have bottomed and upper-teens EPS (earnings per share) growth looks possible over next two financial years.
'People should know the names of all such drugs which have been banned.'
The court rejected Chakraborty's bail application. The NCB told the court that she was an 'active member' of a drugs syndicate and procured drugs for Rajput, her boyfriend.
The government on Monday reduced basic customs duty on influenza vaccine and nine other specified life-saving drugs used for treating breast cancer, hepatitis-B, rheumatic arthritis, etc.
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.
The Delhi High Court has asked the Centre reasons for inviting bids for supply of CGHS medicines from drug manufacturers on the basis of brand names instead of their chemical composition and sought an explanation from the government.
The drug Glivec was a genuinely new and important discovery deserving of patent protection.
Many companies globally are working on plasma research to develop and manufacture hyperimmune globulin therapies from plasma donations.
The Bharatiya Janata Party on Thursday released its manifesto for the October 5 Haryana assembly polls, promising a monthly assistance of Rs 2,100 for women, two lakh government jobs for the youth and guaranteed government job for Agniveers hailing from the state.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
Three employees of a Noida-based pharmaceutical firm, whose cough syrup is alleged to have led to the death of 18 children in Uzbekistan last year, were arrested on charges of manufacturing and sale of adulterated drugs, officials said.
The 344 banned drugs include the fixed dose combination of Chlopheniramine Maleate and Codeine syrup sold under the popular cough syrup brand Corex.
If a show about Gujaratis or Indians in the US had to be made, it could have been more authentic, sighs Deepa Gahlot.
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.
Merck alleges violation of its patent for anti-diabetes drugs Januvia and Janumet.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
