Few drugs in the market are not approved by the authorities and can be life-threatening.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
The new guidelines, effective from August 1, aim to expedite visa approvals for nationals from China and other countries sharing land borders with India.
The Food Safety and Standards Authority of India (FSSAI) has commissioned a quality check on MDH and Everest products. This follows complaints that several popular spice mixes of the two leading brands contained traces of ethylene oxide more than the permissible levels, official sources said. This move by FSSAI comes after Hong Kong and Singapore recalled variants of the two masala majors' products in their countries.
Medicines that fall under Schedule H category (class of prescription drugs) would be provided against a valid prescription that can be submitted either physically or over e-mail. Narcotics, psychotropics and controlled substances, though, cannot be delivered.
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 drug regulator recently asked some domestic companies to cut prices of insulin while MNCs, which are major players, are allowed to set their own price for the drug.
If a show about Gujaratis or Indians in the US had to be made, it could have been more authentic, sighs Deepa Gahlot.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
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 Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
Ankleshwar plant is the third such facility to face action
The panel headed by Justice (retired) Ritu Raj Awasthi has submitted its report to the government, calling for an exhaustive overhaul of the law.
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).
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
According to highly placed sources in NPPA, the reduction in prices following the latest exercise will range between six and 53 per cent.
'Any dietary approach is incomplete without physical exercise.' 'Application of calorie restriction/intermittent fasting alone would lead to a decrease in muscle mass, and possibly bone mass too.'
The drug pricing regulator on Tuesday said it will fix the ceiling prices of over 300 medicines by the end of this month, a move that will come as a major relief to patients.
While Lupin is working on a Remdesivir powder for inhalation, Glenmark has tied up with a Canadian Biotech firm for nitric oxide nasal spray that reduces Sars-CoV-2 viral load and thus transmission.
The Directorate General of Civil Aviation (DGCA) has released a draft procedure that calls for testing pilots, other aviation personnel and crew members for psychoactive substances before they take to the skies. The Indian civil aviation regulator has sought comments from stakeholders over the next 30 days before issuing a regulation to this effect. Asking airlines and airports to do random checks on crew and air traffic controllers, DGCA proposed that violators be suspended for a minimum of three years or their licence be permanently cancelled as maximum punishment.
But it is not clear when the jabs will arrive in the country as a consensus on the indemnity clause is yet to be reached, sources said.
The Serum Institute of India is the first Indian company to seek approval for the COVID-19 booster dose.
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.
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.
Security breach came days after the firm got approval to conduct trials for Covid-19 vaccine candidate Sputnik V.
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
Regulator mentions Wockhardt as manufacturer but firm says it only markets drug.
The petitioner's lawyer interjected the rules are being framed for the last 5-6 years but nothing concrete has been done yet.
Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.
The company was indicted for violations at one of its US facilities in 2009, even after Daiichi Sankyo took over as majority shareholder in 2008.
The bone of contention is product approvals, which pharma and neutraceuticals companies say cannot be re-introduced through the regulation route
This move is expected to benefit 22 lakh cancer patients in the country.
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
'However, we have seen weakness in our active pharmaceutical ingredients business.'
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.
But no extra risk after second dose, shows study led and funded by drug maker, reports Sohini Das.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
Ranbaxy Laboratories on Thursday said it will co-operate fully with any regulator from anywhere in the world wanting to investigate its manufacturing practices.
The USFDA has accused Ranbaxy of falsifying data and test results of medicines. A Daiichi Sankyo statement said it takes the issue very seriously. 'Both Daiichi and Ranbaxy have formed a team to solve the issue. Ranbaxy will be responding to the FDA and will continue to cooperate with the agency.' Ranbaxy shares fell more than 18 per cent to Rs 169.85 today on the Bombay Stock Exchange, while Daiichi stock dropped about 10 per cent to yen 1,680 on the Tokyo Stock Exchange.
