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The timing of the directive, issued this month, is surprising as the industry is actively discussing the means to streamline public procurement of medical devices without disturbing the demand-supply equation.
A Roche India spokesperson confirmed the development and said an announcement for a new India head will be made soon. “Dec. 1 will be the date for Lara to end the assignment. During her tenure at Roche India, Lara successfully led the organization with passion and commitment and shaped the culture of the organization,”the statement added.
The Department-related Parliamentary Standing Committee on Health and Family Welfare, in its 115th report submitted in Rajya Sabha on Wednesday, said an earlier document had recognized the need to build capacity of existing human resource in the health care sector to address the shortage of healthcare professionals.
This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its arm Biocon Biologics and Mylan to scale up capacity multi-fold and address the growing market opportunities in US and other global markets.
A consensus to this effect was reached at a meeting held on Friday between the drug pricing regulator, pharma lobby groups and industry associations, said people present at the meeting. The 30% cap on trade margins was preferred over other proposals such as imposing a flat 100% trade margin on all medicines, including those within price control.
The company said that since this manufacturing facility is already under USFDA import alert and presently not doing any US business, this will have no impact on company's current on-going business activities. The USFDA inspection of its Piparia (Silvassa) formulations manufacturing unit in August resulted in three observations.
Indoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the inspection carried out by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from August 5 to August 9, 2019," the filing said.
"Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food & Drug Administration (USFDA) for metformin hydrochloride extended release tablets USP, 500 mg and 1000 mg, the generic version of Glumetza extended release tablets, 500 mg and 1,000 mg, of Salix Pharmaceuticals Inc," the drug maker said in a filing to BSE.
In an article published in the reputed British Medical Journal (BMJ), doctors and maternal health experts have questioned the “scientific rationale“ and “ethics” of an Indian health ministry announcement that calls on obstetric staff to delay giving oxytocin to women after childbirth until the uterus has expelled the placenta.
The stipulation for US or European regulatory approval excludes local manufacturers from tenders and to level the playing field, it is recommended that there should be preference for Make in India products during public procurement, the Department of Pharmaceuticals said in a recent letter to the states
The Enforcement Directorate has sought extension of police custody of former Fortis Healthcare promoter Malvinder Singh & Sunil Godhwani, former CMD of Religare Enterprises Limited (REL) till November 28. The agency had taken both into custody on Nov 14 from Tihar, where they had been lodged due to a case filed by the Delhi Police, related to the alleged scam.
In September last year, the USD three billion drug maker said its US subsidiary entered into an agreement to acquire commercial operations and three manufacturing facilities in America from Sandoz Inc, USA, a Novartis Division, for USD 900 million.
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility management procedures along with lapses in the design of the manufacturing plant. The same unit had come under the FDA radar in March 2018.
The company has completed the pre approval inspection (PAI) for an active pharmaceutical ingredient (API) manufactured at its Units 1&3, located at Visakhapatnam by the United States Food and Drug Administration, Laurus Labs said in a filing to the BSE. The inspection was completed with three observations, 'which are procedural in nature'.
The company which won the tender to market Olanzapine drug in China, is expected to launch it beginning next year, the official said. The products are manufactured either in the plant owned by KRRP in China, or partners in China, or in India by Dr. Reddy's, the official further said.
