The All India Drugs Control Officers Confederation (AIDCOC) has demanded that the Union health ministry suspend the approval granted to 33 drugs for sale in India with immediate effect, as the approval was given without conducting the required clinical trials.
The federation claimed that the Central Drugs Standard Control Organisation (CDSCO) had granted permission for the marketing of 33 drugs without carrying out clinical trials in India. Recently, the Parliamentary Standing Committee on health had found that between 2008 and 2010, 33 new foreign drugs were approved for marketing without phase III clinical trials on patients.
R. Uday Bhaskar, secretary-general of AIDCOC, criticised the CDSCO for its “nexus with pharmaceutical companies who are, in turn, in collusion with medical experts to obtain clearance for the drugs”. He said: “We want a thorough investigation in the case in the interest of the public.” The government should cancel the manufacturing or sale license of the drug manufacturers,” he said.
Sale of antibiotics without prescription is rampant
Despite the government regulations restricting the sale of drugs without a prescription, medical stores continue to do so in the absence of active government monitoring. In particular, antibiotics can be obtained at medical stores just by naming them. Doctors say such an unchecked sale of antibiotics is harmful from the public's perspective.
Even though the policy framework of the Directorate General of Health Services seeks to regulate the unauthorised sale of antibiotics, the practice is rampant. When asked by this correspondent for an antibiotic Azithromycin in a medical store, the owner replied, “500 mg or 250 mg?” The unchecked sale of antibiotics is alarming in the context of studies about the ill-effects of antibiotics. Dr Ashok Varma, GM, Yashoda, says there are clear rules regarding the sale of antibiotics, but that there is no monitoring. “There were certain and clear rules set by the Drug Control Authority for pharmacists, not restricted to just antibiotics, but about the sale of any drug without prescription. But who cares?”
In general, medical stores are the first point of contact for patients, as they tend to ask a pharmacist for medicines rather than consulting a doctor. Dr C. Anjaneyulu, ENT surgeon at Asian ENT Care Centre and an alumnus of AIIMS, says patients often come to him after a period of dosage of Azithromycin. This, he says, does not allow him to advise the patient against using the anti-biotic in case of a history of disease. The antibiotic is used to treat respiratory diseases but is not prescribed to heart and kidney patients.
The Parliamentary Standing Committee made the following onservations on some medicines available in India :
* For 11 drugs, the mandated Phase III clinical trials were not conducted. 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);
* Clinical trials were conducted for Dronedarone (Sanofi) and Aliskiran (Novartis) on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients.
* In case of Irsogladine (Macleods), trials were conducted at just two hospitals as against legal requirement of 3-4 sites
* Mandatory phase III clinical trials were not conducted and the opinion of experts was not sought.
Everolimus (Novartis);
Buclizine (UCB); Pemetexid (Eli Lilly)
FDC (Pregabalin)
* 13 drugs did not have permission for sale in any developed countries. None of these drugs have any special relevance to India.
Buclizine (UCB); Nimesulide (Panacea); Doxofylline (Mars); Pregabalin (Theon); Nimesulide with levocetirizine (Panacea); Tolperisone with Paracetamol (Themis); Etodolac with 28 Paracetamol (FDC); Aceclofenac with Thiocolchicoside (Ravenbhel); Ofloxacin with Ornidazole (Venus)
Aceclofenac with Drotaverine (Themis); Glucosamine with Ibuprofen (Centaur)
Diclofenac with Serratiopeptidase (Emcure)
Gemifloxacin with Ambroxol (Hetero)