The central government has for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids used to make pain-killers, cough syrups, and even cancer drugs. Two government factories in Ghazipur, Uttar Pradesh, and Neemuch, Madhya Pradesh, do the work yet, processing some 800 tonnes of opium gum annually to extract alkaloids. The government on Tuesday gave Thane-based Bajaj Healthcare an initial contract to process 500 tonnes of opium gum annually and wants production to be at 800 tonnes per annum (tpa) in the next five years, indicating the state's exit from the highly-regulated sector.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
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.
Vaccine development is a long process to ensure safety and efficacy through different stages and involves regulatory supervision every step of the way. Ruchika Chitravanshi takes you through this carefully drawn journey of vaccine development.
Semenya has vowed to fight the regulations, but has already lost an appeal to the Court of Arbitration for Sport, and another subsequent plea to the Swiss Federal Tribunal (SFT) asking for the CAS ruling to be set aside.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
The Oxford vaccine, which also has a tie-up with the Serum Institute of India, was first administered to Brian Pinker, an 82-year-old Oxford-born dialysis patient. Pinker is among the first to be vaccinated by the Oxford University Hospital's (OUH) chief nurse, hailed as a major milestone in the phased vaccination programme being undertaken by the National Health Service (NHS).
Facing a steep rise in raw material and interest costs, pharmaceutical companies have sought an increase in prices of regulated medicines, saying otherwise they may be forced to curtail production of certain medicines that have become unprofitable.
Singh brothers might be stopped by 'fit & proper' hurdle due to US drug norm violations; firm says confident of qualifying.
The Gurgaon-headquartered drug maker, set to be acquired by another leading domestic company, Sun Pharmaceutical Industries, reported a consolidated net loss of Rs 186 crore for the quarter ended June.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
IT, pharma and FMCG stocks are the top performers in 2013.
Finance enthusiasts are like gun advocates who say that 'guns don't kill people, people kill people'.
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
Laws governing compensation in case of adverse side effects for Covaxin and Covishield may differ in accordance with the kind of approvals given, say legal experts.
Negotiators from were expected to meet in New Delhi on August 28.
Millions of people across the country stayed indoors on March 22, 2020 in an unprecedented and overwhelming response to Prime Minister Narendra Modi's appeal for the nationwide curfew. People used to come out briefly at 5 pm to show their gratitude to healthcare and other essential service providers with sounds of bells, conches and claps.
The government said that "in exercise of extraordinary powers in public interest, conferred by paragraph 19 of the DPCO, 2013", the ceiling prices of 21 key formulations had been increased. These formulations include common medicines like BCG vaccines, penicillin, malaria and leprosy medicines (Dapsone), life-saving drugs like Furosemide (used to treat fluid build-up due to heart failure, liver scarring, or kidney disease), vitamin C, some common antibiotics, and anti-allergy medicines.
The first nationwide mock drill was held on January 2 which, the health ministry said, helped to iron out any glitches in the final execution and further refinement of the operational procedures.
The ICMR is working on a war footing to develop the testing ecosystem -- especially for the screening blood tests. NIV, Pune, is in the process of validating antibody-based screening kits.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
On the gaining side, Hero Moto, SBI, HDFC, HUL and L&T have gained between 1-1.4 per cent.
Don't be afraid to prioritise your sexual well-being and nurture a positive relationship with sex, suggests Maitri Trivedi.
'Scientific data has proven that masks can reduce COVID-91 transmission by 53 per cent...A booster dose of vaccine, even if it works, is just a temporary fix'
'He came back from the US only to work for his country.' 'He has invested his fortunes to build this company and is married to his work.' 'Rarely does one see such commitment.'
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
He responded to criticism in certain circles following emergency use authorisation to the vaccine and said,"Indian companies do not deserve this backlash".
Hospitals and medical research organisations that conduct clinical trials on humans may soon face surprise inspections from the regulatory authorities. The hospitals, the sponsor pharma companies and the institutional ethics committees that oversee these trials will all come under the regulator's scanner.
India's top vaccinologist Gagandeep Kang stressed the need to develop better vaccines that can deal with new variants, and strengthening of the regulatory mechanisms.
Sri Lanka opening batsman Upul Tharanga tested positive for an banned substance at this year's World Cup, an International Cricket Council (ICC) source told Reuters on Sunday.
As India gets ready to roll out one of the largest vaccine programmes, billionaire Mukesh Ambani on Tuesday said his group is working with authorities to provide technology tools and backbone for mass inoculation against COVID-19. Ambani's telecom venture Jio was rolled out four years back, offering free voice calling and dirt-cheap data. Today, Jio is India's largest telecom operator with over 400 million users, each connected to the internet. At a Facebook event, Ambani said the government's digital push kept the country running even during the pandemic and is now helping in the rollout of one of the largest vaccination programmes.
These items will remain under essential commodities segment till June-end, a move aimed at ensuring availability at reasonable prices and cracking down on hoarders/black marketeers.
The government's agenda also includes the Cryptocurrency and Regulation of Official Digital Currency Bill, 2021.
The UK's medicines regulator on Thursday approved a new antibody treatment against COVID-19, which it believes will also be effective against new variants such as Omicron.
By 2022, there is a plan to make an mRNA-technology vaccine, for which it has tied up with Canadian firm Providence Therapeutics.
Choubey said till February 4 total 81 AEFIs, which is 0.096 per cent of the total beneficiaries who have been administered Covaxin, have been reported.
'This government did not have any plan for safety stocks of essential medicines.'
Consultants are working with various teams on manufacturing, R&D, etc, to assess per-month productivity of each department.
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.
