Industry experts want the Drug Controller of India to intervene in the matter of J&J baby powder failing the quality test in the country.
The order was issued as the product failed the pH test. It does not say anything about the use of asbestos, a carcinogen, in the product, over which Johnson & Johnson faces many lawsuits.
India's drug regulator could be pulled up for several lapses, but in the J&J talc case, it has ticked the boxes
There is little evidence from their global track record to inspire confidence in MNCs and personal care giants voluntarily complying with global product safety standards in every country unless the local regulators insist
While experts questioned the company’s decision not to immediately withdraw the product that’s said to contain cancer-causing asbestos, the Indian drug regulator is silent.
What's shameful is that this criminal waste was a consequence of the kind of poor manufacturing practices that Indian pharma companies usually find themselves accused of
The vaccine’s protection was consistent across Black, Hispanic and white volunteers, and also across different ages.
The court issued notice to the Centre, NAPA and Director General of Anti-Profiteering seeking their stand on the company's petition challenging the direction to deposit the allegedly profiteered amount in a consumer welfare fund.
The court also sought response of the Centre, NAPA, and Director General of Anti-Profiteering on the company's petition challenging the show cause notice and penalty notice to it.
An Australian Federal Court in Sydney found that J&J subsidiary Ethicon had sold the devices without warning women about the potential risks.
The company, through senior advocate Amit Sibal, clarified that the payment should not be considered as an admission of liability or a precedent.
A bench comprising Chief Justice Ranjan Gogoi and Justice S K Kaul considered the response filed by the Union Health Ministry which said that a compensation scheme has been formulated by it to ensure proper compensation to the victims of faulty hip implants.
The patients said that they will not participate in the compensation process in its present form and unless their concerns are addressed.
Dr Raju Vaishya, joint replacement surgeon at Apollo Hospital, said incidentally there is no government body like a national joint replacement registry in our country, though the formation of such a body was suggested years ago.
In case the affected patients intend to approach the central expert committee, they may write to the legal cell of the Central Drugs Standard Control Organisation, FDA Bhavan on Kotla Road, New Delhi.
The expert committee has recommended making the company liable to pay Rs 20 lakh per patient and also continue their reimbursement scheme for revision surgeries till August 2025.
The company along with the government of India is working to bring the most impactable drug for tuberculosis - Bedaquiline to people said Executive Vice President Paul Stoffels of Johnson & Johnson.
It is a molecule we are working with the Government of India. It is Bedaquiline (drug). It is the first new molecule in last forty years (for TB). It is a very impactable drug for multi-drug therapy...we are working with the government to bring it to the people," Stoffels told reporters on the sidelines of BioAsia-2017 being held here.
Madhya Pradesh officials have collected samples from eight cities in the state. The test results will be sent to India's child rights body National Commission for Protection of Child Rights (NCPCR) by this week.
Through the deal, Strides will buy Johnson and Johnson's seven brands in dermatology, anti-emetic and pain management segments. The brands Strides will acquire include Otogesic ear drops, Ethnorub ointment and Stugil tablets.
TB is a major concern in India with an estimated 2.8 million cases of the disease. Around 64,000 people have been diagnosed with MDR-TB in the country so far.
Basically Sun Pharmaceuticals was the only other supplier of Doxil generic (to treat cancer) in the US market. J&J was the innovator of the drug.
The brokerage house sees benefit from Doxil (to treat cancer) shortage in the US and expect the company to make more than USD 150 million from this product in FY14.
The company began supplying Doxil on Special FDA importation last year owing to shortages in the US and finally received approval in Feb 2013 becoming the only other player besides the innovator in the space.
The Bombay HC has remanded the matter back to the Appellate Authority, directing it to hear J&J‘s application afresh. Armed with this order from the Bombay HC, J&J can now resume operations at its Mulund facility, which had been shut since June.