The Union health ministry has issued draft rules to mandate a blue vertical strip on all antimicrobial drug labels, aiming to rein in over-the-counter misuse and tackle India's growing antimicrobial resistance (AMR) problem.
The Union health ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 milligrams for human use, citing health risks.
At present, there is no provision under Drugs Rules, 1945 to address issues of wrong information to obtain regulatory approvals.
Drug regulator DCGI has asked drug controllers of all states and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical -- N-Nitrosodimethylamine -- in antacid Ranitidine.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as 'cocktail' drugs.
Codeine-based formulations are under the scanner for misuse as a narcotic product.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
The original list had named 349 drugs, but 15 drugs, approved prior to 1988, have been kept outside the purview of the ban
The change in labelling, which is seen as a part of government's effort to push generic drugs, will come into effect from September 13.
Experts believe the move will have little impact given limited production of generic drugs and authority of doctors in prescribing medicines.
The Delhi high court had earlier allowed Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination that is banned.
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The Drugs Controller General of India is considering the recommendations of its advisory body to revoke the suspension of the sale of analgin-based medicines in the country.
Some of the popular brands that would be impacted include Phensedyl (Abbott), Tixylix (Abbott), Gluconorm PG (Lupin), Ascoril D (Glenmark), Solvin Cold (Ipca), D Cold Total (Paras Pharma).
After recognising its adverse health effects, the govt has now dismissed its own lab reports to conclude that the evidence against plastic is insufficient.
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
E-cigarettes pose a huge health risk to users, who more often than not are adolescents and young adults
Besides opposing the suspension of three medicines, the sector has also questioned the process adopted by the government.
Popular antacid Mucaine Gel, manufactured by Pfizer's subsidiary Wyeth Laboratories, was also found laced with the heavy metals as well as cadmium.
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