The manufacturing licence of Noida-based pharmaceutical firm Marion Biotech has been cancelled by the Uttar Pradesh authorities, according to officials.
Alkem Labs was issued drug alerts twice last year -- in June and July -- for its drug Glimekem.
With an eye on improving quality assurance in the wake of increased global scrutiny on Indian pharma products, the Centre on Tuesday said that Schedule M of the Drugs and Cosmetics Act, 1940 will be made compulsory for small and medium scale manufacturers in a phased manner. Union Health Minister Mansukh Mandaviya has asked micro-small and medium enterprises in pharma manufacturing to move towards good manufacturing practices (GMP) through self regulation. "This will help in quality assurance and also reduce compliance burden," Mandaviya.
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.
The USTR report, released just ahead of the US' April 2 deadline for implementing reciprocal tariffs, has also cited high tariffs and price caps, which have not increased in line with inflation, as key obstacles for US businesses.
'What India has done will surely embolden more countries to stand up to Trump.'
'We recently launched Yesintek in the immunology space.'
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
Donald Trump's tariffs, meant as political punishment, have avoided the predicted chaos, lifting US growth, weakening rivals, and letting him claim victory in a resilient global economy, observes T T Ram Mohan.
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.
A large number of medical device-manufacturing units have been forced to move to Vietnam and Malaysia due to delays, inconsistent timelines, and a lack of transparency in licensing processes, according to the Parliamentary Standing Committee on Health and Family Welfare.
The Centre is considering a proposal on increasing coverage under the Ayushman Bharat scheme to Rs 10 lakh from the current Rs 5 lakh.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
Ahmedabad-based Zydus Lifesciences said on Tuesday that a new drug application for its oral drug Desidustat used in treating anaemia in chronic kidney disease (CKD) patients had been accepted by the National Medical Products Administration of China (NMPA). In 2020, CMS International Development and Management Ltd, a wholly-owned subsidiary of China Medical System Holdings Ltd obtained an exclusive license for the product from Zydus. CKD involves a gradual loss of functioning of kidneys and eventually leads to kidney failure.
All doctors must prescribe generic drugs, failing which they will be penalised and even their license to practice may also be suspended for a period, according to the new regulations issued by the National Medical Commission (NMC).
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
After falling 17 per cent since the start of the year to its March lows, the stock of the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries, has clawed back nearly half of those losses. Recent acquisitions, a favourable court ruling in the case of the hair loss drug Leqselvi, an edge over peers owing to its specialty portfolio, and a diversified global presence have supported the recovery.
An increase in the number of outsourcing deals between domestic drug companies and pharmaceutical multinationals has triggered huge capacity expansion programmes in the drug manufacturing sector.
The CBI has significantly increased the rate of fugitive repatriation, bringing back 134 individuals in the last five years, doubling the number from the previous decade. This success is attributed to enhanced diplomatic efforts, technological advancements, and improved coordination with Interpol.
Indian Council of Medical Research had also recommended the use of hydroxychloroquine for treating healthcare workers handling suspected or confirmed coronavirus cases and also the asymptomatic household contacts of the lab-confirmed cases.
In a double-dose bid to boost growth and employment prospects, the Union Cabinet on Tuesday approved a Rs 2.07 trillion outlay for a research development and innovation (RDI) Scheme to fund private sector innovations, and an employment-linked incentive (ELI) to create over 35 million new jobs over the next two years.
The Bombay high court on Monday said no coercive steps shall be taken against IRS officer Sameer Wankhede till April 10 on notices issued to him on the NCB's preliminary inquiry over irregularities in a drugs case related to actor Sushant Singh Rajput's death.
India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
While extending the National List of Essential Medicines will help patients, care has to be taken to ensure this does not lead to a slowdown of production as has happened in case of DPCO drugs.
Germany's drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by India's pharmaceutical research company GVK Biosciences were "insufficient".
He was on Wednesday produced before a magistrate in suburban Andheri which remanded him in police custody till October 23 in the same mephedrone seizure case.
Pharmaceutical companies in the country offering any financial incentive to doctors to prescribe particular drugs may become a thing of the past if the drug manufacturers decide to follow the strict code of conduct being implemented by a US industry trade group.
A notification of the revised Schedule M rules by the Ministry of Health and Family Welfare has elicited mixed responses from the pharma sector and industry observers. While the industry has welcomed the revision of rules, several analysts said that implementation and compliance can become a challenge for smaller pharmaceutical companies. The Schedule M of the Drugs and Cosmetics Rules specifies the good manufacturing practices (GMPs), which aim to ensure quality of drugs made in the country.
The company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
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.
Novartis markets Nilotinib globally as Tasigna, which is used as the second-line therapy for Gleevec-resistant patients in the case of chronic myelogenous leukemia.
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.
The company will supply the drug to major government as well as private hospitals across India, Dr Reddy's said in a regulatory filing.
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,
According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import new drug for 'compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need', which has not been permitted in the country, but under Phase-III clinical trial (human trial) in the country or abroad, by making an application to the Central Drug Regulator.
Indian pharmaceutical companies may have units abroad as part of "distributed manufacturing" across various locations, according to industry veterans. This may come about over the next five to 10 years.
According to the Department of Pharmaceuticals' annual report for 2024-25, India imported medical devices worth $8.1 billion, while exports stood at $3.7 billion in the financial year 2023-24 (FY24)
Agriculture, pharma, electronics, and engineering goods together accounted for over 50 per cent of India's merchandise exports in 2024-25, according to government data, highlighting the country's growing strength in diverse sectors amid efforts to boost manufacturing and value-added exports.
Drug major Ranbaxy on Wednesday said it has received approval from the Australian health regulator to market its antipsychotic drug Ozidal Risperidone in that country.
