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.
India has so far banned over 80 specific drugs and fixed-dose combination of drugs from being sold in the country.
Human aqueous Placental extract is a very effective drug. It contains several bioactive therapeutic molecules. We (the team of Indian Institute of Chemical Biology, an unit of CSIR India) are working for last 12 years with the extract the trade name is ‘Placentrex’ and identified different molecules with the potent therapeutic efficacy e.g. fibronectin type III like peptide, Bioactive NADPH, PDRNs , some other peptides with protease regulatory property etc. Banning this drug is a loss of a huge number of populations suffering from chronic, non-healing /diabetic wounds, burn injuries, surgical trauma etc. These research findings have been published in highly reputed international (Us and UK based) as well as national journals (ref Pubmed). It’s an Indian drug with a very good reputation in abroad like France, Switzerland, Korea etc. We have been invited several times in abroad (Europe, especially in France) to deliver lectures on ‘Placentrex’ research findings. We are still working with the drug. So far we have not found any adverse effect of the drug. Several clinical studies have also been done on it and these are also published in different peer-reviewed medical journals. Without knowing the rationality, efficacy and safety ‘Banning this highly reputed product of India’ is very much unethical. Banning of such a globally accepted drug must be reconsidered.
ReplyDeleteMy strongest support is with the above comments. Research findings on indigenous human placental extract which is available at pubmed(www.pubmed.com)is very rational, based on extremely scientific foundation. Efficacy of the drug is unquestionable and it has been accepted by the global scientific community through several high rated international and National scientific journals. Banning of such a successful Indian formulation is a shame for the country itself. Through the research on this placental extract our country has been glorified several times. Without knowing the actual fact, banning the drug is a shameful as per my opinion.
ReplyDeleteI have been using placentrex for past 4 yrs I have noticed no side effects. the drug is very good for wounds it is economical and in a country like India such effective drugs should be promoted rather than banned.
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