Pune-based Serum Institute of India (SII), Reliance Life Sciences, Dr Reddy's Laboratories, Biological E and two state-owned units - Mumbai-based Haffkine Ins ..
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Reliance Life Sciences to conduct phase 1 clinical trial of its recombinant protein-based Covid-19 vaccine candidate.
Over the past three years, RIL has announced USD 3.1 billion in acquisitions with 13 per cent in retail, 80 per cent in telecom, media and technology, and 6 per cent in energy.
Reliance Life Sciences, the biopharmaceutical unit of Reliance IndustriesBSE 0.90 %, has acquired the global rights for biosimilars, or copies, of Infliximab from Boston based Epirus Biopharmaceuticals. Infliximab is used to treat a broad range of medical conditions like rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
After Biocon and Mylan , Reliance Life Sciences has approached the Delhi High Court to appeal against an earlier order that imposed marketing restrictions to its copy of Swiss biotech giant Roche's breast cancer drug , Herclon (trastuzumab).
Swiss biotechnology giant Roche has sued the Drug Controller General of India in Delhi High Court along with Hyderabad-based Hetero Drugs over the process followed for approval of copies of complex biotech drugs or biosimilars of Avastin (bevacizumab), its blockbuster brand that is used to treat at least six forms of advanced cancers.
On January 19, 2016, the Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee – Oncology (Oncology SEC) met to discuss several proposals for clinical trials. Amongst the biological division proposals reviewed by the committee included Biocad’s request to continue its Phase III trial for a biosimilar version of Herceptin (Trastuzumab) in order to move towards final approval from the Drug Controller General of India (DCGI). Specifically, Biocad presented data from its current ongoing Phase III Global Clinical Trial that included forty (40) Indian patients out of which only twenty-three (23) patients had completed all the cycles. As a result, Biocad requested the committee to allow it to continue its Phase III trial. Instead, the committee recommended that the company submit a new Phase III Clinical Trial Protocol with proper sample size calculation.
On January 19, 2016, Gland Chemicals Private Limited (Gland) secured Written Certifications of Exports to the European Union from the Central Drugs Standard Control Organization (CDSCO) for three (3) of its active pharmaceutical ingredients (APIs), including:
Reliance Life Sciences has received approval from the US drug regulator for its active pharmaceutical ingredient (API) manufacturing facility located at Dhirubhai Ambani Life Sciences Centre in Navi Mumbai. The biopharmaceutical arm of Mukesh Ambani-led Reliance group has received the approval at a time when Indian generic drug makers are increasingly grappling with regulatory action from the US Food and Drug Administration.