The recent recalls come amid increased FDA scrutiny of medicines produced in India.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
Maggi has also come on the radar of US Food and Drug Administration.
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.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
The TIME 100 AI list is an interesting assortment of titans. Indians make up about 20 per cent of the coveted list, which is pretty commendable, notes Sandeep Goyal.
Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.
China's API exports to India touched $3.3 billion last year, while Indian drugs struggled to post $500 million worth of exports to China.
While sales in the domestic market declined 4.2 per cent during the April-July period, exports grew steadily at 9.5 per cent during the same period.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
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.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
The number of dollar billionaires in India has risen to 55 this year from 46 last year.
The court had provided a conditional relief to Nestle India.
The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
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.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
The trouble for Nestle's Maggi started in Uttar Pradesh last month and has now spread nationwide. The Food and Drug Administration has directed all states on Wednesday to get sample of India's most popular instant noodles tested for high content of lead and mono-sodium glutamate, a taste enhancer.
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 company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
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.
India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
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.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
