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.
The percentage of non-standard quality drugs in the state has been in the range of 2-2.5% as compared to an all-India average of 5-6%
The vaccine option for this age group would only be Covaxin, according to guidelines issued by the Union Health Ministry on December 27.
'We have got enough internal accruals, and we are able to do acquisitions on our own.'
Security agencies could track the flight path and even address of criminals involved in this cross-border illegal activity that is rearing its head over the last few years, he said on Saturday.
Opposition parties targeted the Chief Minister Bhagwant Mann-led state government over the law and order situation and demanded that he step down on moral grounds.
The Union home ministry said several steps have been taken to augment the production and supply of Remdesivir injections from 38.80 lakh units per month to 74 lakh units per month by early next month, and asked the states to ensure its seamless supply and transport.
Unlike India, the US is a free-pricing market.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
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.
Nothing is going to change in a hurry unless attitudes change and punishments are speedy and fair, notes Ramesh Menon.
'The jungles of Doda covers about 250 km.' 'Sleeper cells are providing active help to the terrorists.' 'The terrain and situation is such that it is not possible to keep track of every inch.'
The current total installed capacity of the seven manufacturers of remdesivir is 38.80 lakh vials per month, the Ministry of Chemicals and Fertilizers said in a statement.
Wankhede, whose interim protection from arrest in the Central Bureau of Investigation's case of extortion and bribery against him was on Thursday extended by the HC till June 23, in his rejoinder affidavit claimed the SET has 'twisted facts and labelled false allegations to jeopardise the career and character of honest officials'.
The Narcotics Control Bureau on Tuesday claimed to have busted the "biggest" darknet-based LSD cartel operating in India with the seizure of more than 13,000 blots and Rs 26 lakh in cash and the arrest of three persons.
Currently, the govt directly caps prices of 348 formulations at the average price of all medicines in a particular segment with at least 1% market share
These drugs will be entering in their global Phase -3 clinical trials early next year.
Sameer Wankhede claimed that CBI officials took the phone of his wife Kranti Redkar in their possession.
Regulator mentions Wockhardt as manufacturer but firm says it only markets drug.
Orders surprise inspections at chemists and pharma stores.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
The petition, filed through advocate Rizwan Merchant, claimed that after concluding the investigation in the case, a draft complaint was prepared by the department legal advisor, where charges were proposed against Aryan Khan among others.
Former Mumbai Narcotics Control Bureau (NCB) chief Sameer Wankhede appeared before the Central Bureau of Investigation (CBI) in Mumbai for the second day on Sunday in a case in which he is accused of demanding Rs 25 crore bribe from superstar Shah Rukh Khan for not implicating his son Aryan in the Cordelia cruise 'drug bust' case, an official said.
Roche has already adapted its business model in India to increase affordable access to drugs and try to stave off trouble from India's patent authorities.
Judo's governing body said that athletes were not obliged to take unscheduled drug tests when training in France in June and that those who refused, including Kosovo's gold medallist Majlinda Kelmendi, subsequently tested negative the next week.
The Maharashtra HM had said on Tuesday that the Mumbai police will probe allegations by actor Adhyayan Suman that Ranaut took drugs.
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
Replying to supplementaries during Question Hour in the Lok Sabha, minister of state for chemicals and fertilisers Srikant Jena said the National Pharmaceutical Pricing Authority has been asked to look into demands for bringing 23 anti-cancer drugs within the ambit of price control.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
India and Pakistan on Tuesday agreed to enhance cooperation through "effective and sustained steps" to control illicit drug trade and signed a Memorandum of Understanding to boost efforts to prevent the trafficking of narcotics and precursor chemicals.
Bangalore-based Stempeutics Research received clearance from the Drug Controller General of India to conduct human clinical trials to develop drugs using stem cells. With this, India became the first country after the US to allow human clinical trials to develop drugs by using dormant cells in the body that have natural regeneration capabilities. Once injected into a patient, the stem cells can be controlled with a simple magnet to direct them to the damaged area and cure
The government regulates prices of all other medicines.
However, he also said traditional ayurveda, yoga and naturopathy have also controlled and provided permanent solution to several complex diseases like blood pressure, thyroid, sugar, arthritis, hepatitis and asthma.
China has formally apologised to Nigeria for alleged export of fake drugs including some labelled as 'Made in India' by some Chinese firms to the country and assured to take punitive action against those involved in the scandal.
The NCB claimed that the students were both addicts and suppliers of these drugs.
The World Health Organisation on Friday said that it is in touch with the Uzbek authorities about the reported deaths of 18 children after consuming contaminated cough syrup made by Noida-based Marion Biotech.
Birth control pills increase the risk of ischemic strokes.
