Small scale drug makers fear that they may have to shell out anything between Rs 20 lakh (Rs 2 million) to Rs 1 crore (Rs 10 million) for acquiring land and equipment as mandated by the new GLP.
Pharma major Roche Scientific Company on Tuesday launched its revolutionary anti-cancer drug 'Tarceva' (erlotinib), which 'prolongs and improves' quality of the life of patients, suffering from lung cancer.\n\n
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
The Indian Council of Medical Research is conducting three different studies to ascertain the facts regarding rising cases of cardiac arrest after the pandemic, Mandaviya said in response to a question in the Lok Sabha.
Roche said the Indian regulatory authorities had approved Biocon and Mylan's products as Trastuzumab, but it was unclear if these met the criteria for biosimilar products.
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.
Which entrepreneur would willingly part with her or his hard-earned money for grasping, self-serving politicians? asks Debashis Basu.
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Members of the Congress and AIUDF, protesting against a Cabinet decision to repeal the Assam Muslim Marriages and Divorces Registration Act, 1935, staged walkouts later.
This is a good opportunity for long-term investors to pick quality small and midcap stocks at reasonable valuations.
The WHO on Tuesday issued a product alert over contaminated syrup by an Indian manufacturer, warning that it is unsafe for use, especially in children, and may result in serious injury or death.
The Mumbai police seized more than 700 kg of mephedrone worth Rs 1,400 crore following a raid at a drug manufacturing unit at Nalasopara in Palghar district, and arrested five persons, officials said on Thursday.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
The productivity of the Budget session was abysmal. The Lok Sabha functioned for 33% of its scheduled time (46 hours); the Rajya Sabha 24% (32 hours).
A day before the event, I learnt from an old Mumbai crime branch informant that a group of gangsters were planning to serve breakfast to the prisoners at Balgandharva Rangmandir prior to the show.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
Forty years after its first edition, the world athletics championships get underway in Budapest on Saturday with over 2,000 athletes from 202 countries taking part over nine days of what could be record-breaking action.
The virus was detected in Aedes aegypti mosquitoes after samples from six water bodies in Chikkaballapura were collected and sent for examination.
They said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by the WHO, the committee will advise and recommend further course of action to the Drugs Controller General of India (DCGI).
The report also said that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
Abhishek Chaubey talks about Udta Punjab, his actors and how the drug-themed film happened.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
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.
Despite the hope that lessons will be learnt, the next accident invariably shows that nothing has been learnt -- or if learnt, they have been ignored, observes Prosenjit Datta.
Medicines, including antibiotics, contraceptives and anti-diabetic drugs, were found to be out of stock at various places around Delhi.
GVK Biosciences is the latest Indian firm to come under international scrutiny over quality issues.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
The trailer of the new Kamal Haasan-starrer Thoonga Vanam shows the actor assuming a slick avatar as a cop from the anti-narcotics department, taking on the drug baron Prakash Raj.
India yet to make formal bid for hosting World Athletics Championships in 2027
Unlike India, the US is a free-pricing market.
Mumbai Police have seized "high quality" charas worth Rs 14.44 crore, which was brought from Kashmir in a car, and arrested a man, his wife, daughter and one other person in this connection, an official said on Tuesday.
Dear patients and caregivers, be forewarned. The disease is deadly in the truest sense. Only the mildest forms seem to be curable, and those too, if detected earlier, observes Shreekant Sambrani.
The agency has previously found that alcohol causes at least seven types of cancer, including the most common cancer types, such as bowel cancer and female breast cancer. It is also linked with oesophagus, liver and colorectal cancers.
