Initiates action for alleged adverse reactions of medicines.
The Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator, may soon ban the production and sale of three medicines in the country.
The drugs — cisapride, phenylpropanolamine (PPA) and human placenta extracts — have been controversial medicines for their alleged adverse reactions for several years now.
The CDSCO move comes against the backdrop of its aggressive stance to get rid of drugs that are potentially harmful in the domestic market. A few weeks ago, the drug regulator had suspended the marketing of two medicines – anti-obesity drug sibutramine and anti-diabetic drug rosiglitazone – from sale counters over complaints of adverse reactions.
The market value of the three medicines that are currently being considered for a sale ban were not known, industry analysts said. However, the first two, cisapride and PPA did not have significant market presence, while the third one, human placenta extacts, were being sold as Placentrex lotion, gel, and an inject able remedy for a variety of unrelated disorders such as vitiligo, wound dressing, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc, they added.
According to professional journal Monthly Index of Medical Specialties (MIMS), PPA, widely used in cold and cough remedies, has been banned or discared in all North American and West European countries. Similarly, all products containing extracts of human placenta have been banned by the United States Food and Drug Administration (USFDA) as they transmit diseases and pose serious health hazard to consumers.
“Placenta extract was never permitted for use as medicine in the western countries, such as the US, Canada, Britain, Australia and European Union states, due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. Since April 14, all products containing human placenta extracts even in use as cosmetics have been banned,” MIMS says.
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The apex drug regulator may also take a final view on the marketing status of over 70 fixed-dose combinations of several medicines, with an expert committee recommendation on the rationality of such combinations is expected soon.
“Once the recommendation of the expert committee is ready, we will decide whether or not to continue permission to allow the marketing of such combination medicines in the country,” a senior drug regulatory official said.
CDSCO is also in the process of framing the modalities of recalling such banned drugs from the market. “A committee of five state drug controllers is looking into the matter. Once the guidelines are framed, there will be a system and deadline for the recall of banned drugs from the retail and wholesale outlets,” the official added.
India has so far banned over 80 specific drugs and fixed-dose combination of drugs from being sold in the country.