The following information was given by Minister of Health & Family Welfare Sh. Ghulam Nabi Azad in reply to a question in the Lok Sabha today (March 11, 2011).
Banned Medicines
The Central Government has prohibited six drugs on the recommendations of the Expert Committee constituted by DTAB in view of the safety issues involved in the use of these drugs by a Gazette Notification dated 10.02.2011 with immediate effect. The names of these drugs along with the brief reasons for their ban are furnished below:
1. Nimesulide formulations in children below 12 years of age - Nimesulide containing products are not permitted in many countries in children under 12 years of age. The drug has been considered to be hepatotoxic and children are considered more susceptible to hepatotoxicity.
2. Cisapride and its formulations for human use - Use of this drug is reported to be associated with increased risk of serious cardiac arrhythmia.
3. Phenylpropanolamine and its formulations for human use - Use of this drug is associated with risk of hypertensive episodes like cardiac congestive failures and hemorrhagic strokes.
4. Human Placental Extract and its formulations for human use - There is no clear evidence of efficacy of this drug in most of the conditions and there are safety concerns like transmission of blood borne infections, immunoreactions and unwanted exposure to hormones associated with its use.
5. Sibutramine and its formulations for human use - Use of this drug is associated with increased risk of cardiovascular events such as heart attack and stroke.
6. R-Sibutramine and its formulations for human use - Use of this drug is associated with increased risk of cardiovascular events such as heart attack and stroke.
Apart from the aforementioned six drugs banned recently, the following drugs have been banned during the last three years:
1. Rosiglitazone, on 12th November, 2010 - Use of this drug is associated with increased risk of cardiovascular events such as congestive heart failure and myocardial infarction.
2. Rimonabant, on 11th December, 2009 - Use of this drug is associated with increased risk of psychiatric side effects.
3. Diclofenac and its formulations for animal use, on 4th July, 2008 - Extensive use of this drug in animals was leading to harmful effects on vultures. The vulture population was depleting as it was observed that vultures fed on carcass of animals treated with diclofenac were dying.
The decision to ban or withdraw a drug by the regulatory authorities is normally based on the risk assessment process, which is influenced by a number of factors such as disease pattern in a country, indications and dosages of the drug permitted, varying reactions of certain ethnic groups in a given population, availability of safer substitutes and overall safety profile of the drug. These conditions are different for different countries. It is for this reason that a drug banned / restricted in one country may continue to be marketed in other countries. There is a well laid out mechanism in India to review the status of the drug formulations as and when any serious adverse event is reported in the International journals, WHO Newsletters or when a drug formulation is reported to have been banned / withdrawn in some countries. The use of the drug, so reported, is assessed in consultation with the expert committees set up for the purpose, based on available technical information, benefit-risk ratio, local needs and availability of safer alternatives etc. The Central Government prohibit manufacture and sale of drugs in the country under Section 26A of the Drugs and Cosmetics Act, 1940.
This information was given by Minister of Health & Family Welfare Sh. Ghulam Nabi Azad in reply to a question in the Lok Sabha today.
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Human Placental aqueous Extract is a very safe drug. We the team of IICB, Kolkata ( A Unit of CSIR,India) are working with the drug ‘Placentrex’ since 1999 with extension in every alternate year. A committee constituted by experts approved renewal of the project. Ours is a CSIR owned biomedical research institute of national importance. As per CSIR guidelines on human and animal ethics, it is not possible to undertake any research in the institute, which is hazardous or unsafe to human or animal health or the environment.
ReplyDeleteTwo research scholars Dr. Sangeeta Nath and Ms. Debashree De, were awarded CSIR-senior research fellowship for continuation of their work on ‘Placentrex’ in 2004 and 2007 respectively. The expert committee of CSIR, New Delhi, awarded fellowships after extensive reviewing of research proposals. The committee members were fully aware of the manufacturing of the drug.
Three theses describing research on ‘Placentrex’ have been submitted to Jadavpur University for the award of Ph.D. degree by National and foreign examiners who are experts in the respective fields have evaluated these theses. Nobody raised doubts about bio-safety of the starting materials.
Since 1999, in many occasions we presented research work in front of national and international audiences. The question of safety of the drug has never been raised.Once the germination period was over, we are publishing research articles on ‘Placentrex’ since 2004, in different national and international peer-reviewed journals. It should be noted that no journal would accept a manuscript until the ethical aspects like safety of products are satisfied. Thus it is clear that identified experts have endorsed the safety of the drug in a worldwide fashion. Significantly, a review article is also in print.
List of Publications on Placentrex from IICB (Kolkata, A Unit of CSIR, India)
1. J. Pharma. Biomed. Res. (2004) USA
2. J. Pharma. Biomed. Res. (2004) USA
3. J. Chromat. B (2005) Netherlands
4. Current. Science (2005) India
5. Inter. Immunopharmacol. (2006) UK
6. Indian J. Expt. Biol. (2007) India
7. J. Chromat. B (2009) Netherlands
8. J. Wound Care (2009) U.K. (Review article)
9. Physiol. Update (2009) India
10. J. Cell. Physiol. (2010) USA
In conclusion, it may be summarized that experts of biomedical research have approved the safety of the drug ‘Placentrex’ worldwide since 1999 i.e., as long as we are associated with its research. None of these experts are beneficiaries of ‘Placentrex’ research. So the concern for safety of the drug does not stand on any foundation.
fyi,
Rgds,
Dr. Piyali D. Chakraborty
Welcome to our site!
ReplyDeleteWe appreciate your comments and wish to let you know that we are here to showcase the domain of Human Placental Extract & its formulation for the general public with transparency so that they can get a rational coverage on this subject from around the world.
From IICB team of Calcutta, India who are engaged on the HPE research we expect more comments and feature article(s) on the efficacy of human placental extract & its formulation.
What we have noted is that there's lack of general awareness regarding human placental extract. Just for the sake - that’s Western countries not using it, so we should also "discard" one of our own products is not done. Today there's country restrictions apply for HPE products but one should analyze under what circumstances they have been enforced while its currently being used in Oriental countries with their Govt. approvals and what could be the consequences of it (esp. in India) if such restrictions are withdrawn in western countries.
We can just appeal to Indian Govt. to rethink on this issue……..esp. its being an Indian project (Indian Govt. research organization doing the research, an Indian Pharmaceutical manufacturing Co. producing the product)
Thanks & Regards,