At present, there is no provision under Drugs Rules, 1945 to address issues of wrong information to obtain regulatory approvals.
The Supreme Court on Tuesday reserved its order on the contempt notice issued to yoga guru Ramdev, his aide Balkrishna and Patanjali Ayurved Ltd in the misleading advertisements case.
Ramdev and Balkrishna have tendered an "unconditional and unqualified apology" before the apex court over advertisements issued by the firm making tall claims about the medicinal efficacy of its products.
Hospitals and blood banks can now only charge processing fees for blood as the apex drug regulator has decided to do away with all other fees to check the practice of overcharging.
In an affidavit filed in the top court, the SLA has given details of the steps taken by it against Patanjali and Divya Pharmacy.
Minister of State for Health Bharati Pravin Pawar said 642 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs, while 262 persons were arrested.
The Supreme Court Tuesday granted one-week time to yoga guru Ramdev, his aide Balkrishna and Patanjali Ayurved to issue a public apology in the misleading advertisements case, but said it was not letting them 'off the hook' now.
The notice says the company can restart manufacturing these products only after the authority approves their revised formulation sheets.
Amending the earlier order, the authority on Saturday issued a fresh one allowing the firm to continue the production of these medicines.
The manufacturing licence of Noida-based pharmaceutical firm Marion Biotech has been cancelled by the Uttar Pradesh authorities, according to officials.
Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities. If the licenses don't come through, either due to lack of audits or MSME units not clearing the audits, then a few thousand small-scale medical device units will face the issue of business continuity in three weeks. Class A medical devices are those with low to moderate risk to the patient or user (surgical dressings for example), while Class B medical devices refer to devices with moderate risks that require special controls (catheters for example).
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).
The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi high court order dated December 12, 2018, which prohibits online sales of medicines without a licence.
The ongoing crackdown on Khalistan supporters has brought to light a questionable delay in revoking arms licences granted to the armed guards of radical preacher Amritpal Singh in Jammu and Kashmir, officials said.
A vacation bench of Justices NJ Jamadar and Sharmila Deshmukh passed the decision on Wednesday while hearing a petition filed by the company challenging two orders of the state government.
Under the proposed rules, individuals or companies will have to register with the central licensing authority to run an e-pharmacy; state-wide registration is not required.
The company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.
Ramdev's herbal medicine company Patanjali Ayurved has launched 'Coronil tablet and Swasari vati' medicines claiming they can cure the highly contagious disease within seven days.
The top court was hearing a batch of pleas challenging the direction given by the Jammu and Kashmir high court.
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.
The Kerala high court on Thursday asked the state government as to what steps can be taken to ensure the safety of citizens on the roads in the wake of a bus accident in Palakkad claiming nine lives, including five school students.
"The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the consent form said.
According to a notification issued by the health ministry, medical retailers will be allowed to provide drugs to people at their doorstep.
While Ramdev claimed that Ayurved-based 'Coronil and Swasari' medicine have shown 100 per cent favourable results during clinical trials on COVID-19 infected patients except those on a life support system, the Ayush Ministry sought from the company detailed report on composition, testing and other data of the drugs.
The minister said that his ministry will clear its stance on Patanjali's ayurvedic drugs after reviewing the report sent by it.
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
The new Broadcast Bill is unlikely to be placed in Parliament in the upcoming winter session, official sources said in New Delhi on Friday.
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.
Eleven Indian citizens, who had either overstayed visas or entered Britain illegally, have been arrested following a check of two overcrowded vehicles in Lincolnshire.
Women can now work as bartenders in Karnataka albeit under a dress code that forms part of the government guidelines which received the high court nod on Tuesday.
The Delhi High Court on Friday stayed the ban on some fixed dose combination (FDC) drugs of Glaxo SmithKline, Wockhardt and Laboratories Griffon but said action against their sale could be taken in the absence of valid sale and marketing licence.
State Ayurved Department's licence officer Y S Rawat said the notice is being issued to the firm to explain from where it got the permission to launch a 'corona kit' as a cure from the virus.
Tottenham Hotspur have banned vuvuzelas from their White Hart Lane ground saying the noisy plastic trumpets pose a risk to public safety.
Tightening up the process for grant of arms licence, the central government on Thursday decided to make mandatory a police verification report on the applicant before the document is issued to him.
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 Home Ministry is amending the Arms Act and rules to restrict grant of licence of fire arms and ammunition only to those facing a grave threat to life and that too only after the threat angle is thoroughly examined by the police.