NEW DELHI – With pharmaceutical sector regulations in urgent need of reforms, India has taken the first step, tightening rules for fixed-dose combination (FDC) drugs. Two key drug regulatory agencies, the Drugs Controller General of India and the Central Drugs Standards Control Organisation, have issued notices to several companies, guiding phase IV postmarketing surveillance trials and for manufacturing and selling FDCs in the country without approval from the Drugs Controller General of India. The letters to 283 companies are part of the country’s efforts to examine the safety and efficacy of FDCs licensed for manufacture or sale in the country.
NEW DELHI – With pharmaceutical sector regulations in urgent need of reforms, India has taken the first step, tightening rules for fixed-dose combination (FDC) drugs.
NEW DELHI – While India's tuberculosis (TB) drug industry is generally geared to meet the country's enormous TB burden, which is mainly due to poor patient compliance and multidrug resistance, it is hampered by limited access to high-risk funding and hurdles in regulatory approval.
NEW DELHI – While India's tuberculosis (TB) drug industry is generally geared to meet the country's enormous TB burden, which is mainly due to poor patient compliance and multidrug resistance, it is hampered by limited access to high-risk funding and hurdles in regulatory approval.
NEW DELHI – India is very well placed to tap into the biosimilars opportunities expected in the next 15 years, with its domestic market poised to grow to $40 billion by 2030, against a backdrop of an expected $240 billion growth in the global market, according to a newly released white paper on India's potential in the sector.
NEW DELHI – India is very well placed to tap into the biosimilars opportunities expected in the next 15 years, with its domestic market poised to grow to $40 billion by 2030, against a backdrop of an expected $240 billion growth in the global market, according to a newly released white paper on India’s potential in the sector.
NEW DELHI – India is considering making its voluntary Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) mandatory to curb unfair marketing practices by pharma companies, including providing incentives for doctors to prescribe their products.
