Medical body, All India Drug Control Officers Confederation (AIDCOC), has strongly recommended to the Union Health Ministry, to ban 33 drugs. The AIDCOC has alleged that the Central Drug Standards Control Organization (CDSCO) has given permission for the marketing of these drugs without carrying prior clinical trials in India.
Widespread Sale of Antibiotics without Prescription
To buy antibiotics in India is easy as it does not require a physician’s prescription. Despite restriction in the form of government regulations, the sale of antibiotics without any prescription is widespread.
Observation made by the Parliamentary Standing Committee (PSC)
The PSC made the following observation on certain drugs sold in India. For drugs Everolimus (Novartis), Colistimethate (Cipla), Exemestane (Pharmacia), Buclizine (UCB), Pemetrexid (Eli Lilly), Aliskiren (Novartis), Pentosan (West Coast), Ambrisentan (GlaxoSmithKline), Ademetionine (Akums), Pirfenidone (Cipla), and FDC of Pregabalin, ethylcobolamine, Alpha Lipoic Acid, Pyridoxine & Folic Acid (Theon), no clinical trials were conducted.
For Dronedarone (Sanofi) and Aliskiran (Novartis) clinical trials were conducted on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients.
For Irsogladine (Macleods), trials were conducted at just two hospitals as against legal requirement of 3-4.
No mandatory phase III clinical trials are conducted and no expert advice is sought.