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.
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.
The US-based Dawn Alliance group is planning to set up a United States Food and Drug Administration-approved generic drug manufacturing facility in India.
Alkem Labs was issued drug alerts twice last year -- in June and July -- for its drug Glimekem.
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.
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.
The Centre is considering a proposal on increasing coverage under the Ayushman Bharat scheme to Rs 10 lakh from the current Rs 5 lakh.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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".
Various industry bodies have sought immediate government intervention through the imposition of anti-dumping duties, claiming India has seen a surge in imports of Chinese goods over the past two weeks.
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.
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
The company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
The company will supply the drug to major government as well as private hospitals across India, Dr Reddy's said in a regulatory filing.
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.
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.
A joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.
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.
After registering a net profit of Rs 25.1 crore in Q3FY25 and consolidated revenues growing by 7 per cent on a like-for-like basis, Siddharth Mittal, chief executive officer (CEO) and managing director, Biocon, told Sohini Das/Business Standard in a virtual interaction that local manufacturing in the US is a trade off between cost and qualifying to do business there.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
The Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
