The Gujarat Food & Drugs Control Administration (FDCA) is
stepping up its efforts to stop manufacturing of six drugs recently
banned by the Union Health Ministry.
In a notification issued last month the ministry had banned the
pediatric usage of Nimesulide, a popular pain relief drug, besides
banning Cisapride, PPA, human placental extract based drugs, Sibutramine
with immediate effect. Following this, the Drugs Controller General of
India initiated the process of withdrawing permission to market few
other potentially harmful drugs from the market.
Gujarat FDCA started scanning for manufacturing facilities that manufactured these banned drugs in the state.
"We found that there were around 2188 product licenses for
manufacturing Nimesulide in the state, 1082 licenses for PPA, a common
cold medicine, 36 licenses for Cisapride, and 90 for Sibutramine. We
have already issued notices to manufacturers to stop production of these
drugs. We have not shut down any production facility as any
manufacturer would have multiple licenses pertaining to different
molecules or brands that would be manufactured at the same spot.", said H
G Koshia, commissioner of the Gujarat FDCA.
There are around 3000 licensed drug manufacturing units in Gujarat,
for allopathic, homeopathic and ayurvedic medicines, and around 1.27
lakh product licenses for different molecules and brands.
Industry sources confirmed that all major manufacturers in the state
were into manufacturing these common cold and pain relief medicines.
Koshia also added that as Nimesulide has been banned for children
under the age of 12 years, the FDCA is now in the process of identifying
and hence blocking the manufacture of any pediatric dosage of the drug
in the form of syrups etc. Two more drugs, gatifloxacine and tegaserod
are also likely to be banned soon. The expert committee of the office of
the DCGI has already recommended ban on two such drugs. However, the
ban is yet to be notified by the health ministry. Meanwhile, it may be
mentioned here that the FDCA has withdrawn all measles vaccines under
the brand name Abhay-M belonging to batch number MES 10/10 manufactured
by the human biological institute, a division of Hyderabad-based Indian
Immunological Ltd from the market. Four infants have died on Wednesday.
The Gujarat FDCA has already withdrawn 227 vaccines belonging to batch
number MES 10/10 from across the state. Whereas they have collected
samples from 13 other batches and have sent them to Central Research
Institute (CRI) Kasauli for further testing.
Koshia informed, "The government has set up a high level committee
under the health department to investigate the matter. Till then we have
suspended the programme to avoid further complications. As of now, we
do not know the reason for the death and are waiting for the laboratory
reports. We have already informed the DCGI and the Drugs Control
Adminstration Hyderabad about the same and an enquiry is on.”
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’ project 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.
Two research scholars Dr. S. Nath and Ms. D. 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 (Europe especially France) 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.
Is it the policy of Govt. of India to ban a product which has been proved its unquestionable efficacy through extensive research work? Ironically this high quality research work has been conducted by a reputed research institute of CSIR, India. 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.