Thursday, November 25, 2010

DTAB Urged to Deny Permission to Injectible Contraceptives DMPA


DTAB Urged to Deny Permission to Injectible Contraceptives DMPA

Women’s organizations and leading health experts including Member Population Commission urge the Drug Technical Advisory Board [DTAB] to deny permission to use DMPA in the mass family planning programme

DMPA, Depo medroxy progesterone acetate, a three monthly progestogen only contraceptive injection was licenced for use by the Drugs Controller in the nineties. An intervention petition filed in the matter had led to DTAB restricting its use to private market. The approval itself was based on the manufacturer Max Pharma carrying out post marketing studies as this injection was not properly researched into in India. Even at that time women’s groups had objected to the licencing because of the many contraindications and unmanageable side effects already known.

Since then more data has become available and now its use is linked with loss of bone density and increasing the susceptibility of the user to HIV. In more than fifteen years since the licence was granted there is no reliable treatment for heavy bleeding suffered by a substantial proportion of women administered DMPA.

DTAB at the time had refused to revoke the licence but had restrained the government from using it in the family planning programme as the members had felt that the almost superstitious belief of women in the power of injections would render them to misuse of the injections. The health of the user has to be monitored to watch for the array of disturbing side effects of DMPA. The Indian public health system is too inadequate, inefficient and indifferent to do this work properly. Up to two-thirds of the women on DMPA suffer menstrual chaos which may be culturally unacceptable to women.

Women’s organizations have asserted that contrary to the claims of the health secretary nothing has improved in the public health system. Though the UPA government had promised to increase proportionate expenditure on health this has not materialized. The only personnel that have been added are ill trained ASHAs in the rural areas who have no relevance for delivery of injectable contraceptive.

Further the data from post marketing study done by the Population Council is rather discouraging. Despite training, MBBS doctors had poor recall of contraindications, indications, side effects and management of side effects. Doctors specialising in obsterics and gynaecology [OB/GYNs] were better and the study recommended that these specialists are suitable for delivery of injectables. If the government does not have enough specialists to deal with serious health problems of women, can they be deployed to improve the basket of choices of contraceptives, ask womens’s groups.

They have demanded that in the light of the data thrown up by post marketing studies the DTAB should restrict the use of DMPA to OB/GYNs and extend this restriction for NGOs as well who are using this injection in their programme.

Women’s organizations have consistently opposed the introduction of all long-acting hormonal injectables, including Net-En, and implants such as Norplant, due to their hazardous side effects, potential of abuse and inability of the health system to deliver them safely and they are appalled by repeated attempts of the government to introduce them in the family planning programme in total disregard of the health of women.

Dr. Mohan Rao, Member, Population Commission of India
Dr. Betsy Hartmann, Director, Population and Development Program, Hampshire College, USA
Dr.Veena Poonacha, director, Research Centre for Women' s Studies, SNDT University, Mumbai,
Dr. Nalini Vishvanathan, USA
Anveshi Research Centre for Women's Studies, Hyderabad
Centre for Women’s Development Studies, Delhi
Global Sisterhood Network, Australia
Majlis, Mumbai
Sama Resource Group for Women and Health, Delhi
Saheli women’s Resource Centre, Delhi

November 25,2010, Delhi

Contact, Saheli Women’s Resource Centre, Under Defence Colony Flyover, New Delhi 110024

Wednesday, January 27, 2010

Experts Question Approval of Bt Brinjal

Press Release
Experts Question Approval of Bt Brinjal

Violates Cartagena Protocol & Precautionary Principle

New Delhi 28/1/2010: THE claimed benefits and the apparent risks emerging from inadequate regulatory and monitoring systems of the proposed introduction of Bt Brinjal, a transgenic variety of brinjal were rigorously examined at a Colloquium organised by the Centre of Social Medicine and Community Health (CSMCH), School of Social Sciences, Jawaharlal Nehru University (JNU), New Delhi, in collaboration with Hazards Centre, New Delhi on the 27th of January.

Taking cognisance of the valid questions raised about the conflict of interest ridden Genetic Engineering Approval Committee, the experts recommended adoption of precautionary principles and adherence to Cartagena protocol of which India is a party. The experts at the Colloquium felt that Bt Brinjal requires to be further studied by a trans-disciplinary, independent and impartial team of scientists keeping in mind the short-term and long-term consequences of genetic pollution linked acute and chronic toxicity of food chain.

The Colloquium adopted the following Resolution.

The Centre of Social Medicine and Community Health, School of Social Sciences, Jawaharlal Nehru University, New Delhi, in collaboration with Hazards Centre, New Delhi, organised a Colloquium on Bt Brinjals on the 27th of January 2010. Attended by students and faculty, the house resolved as follows.

Various issues are unresolved about the problematic nature of transgenic technologies in general and Bt in particular. One core issue was the competence, the transparency and the conflict of interest in the regulatory process prior to the grant of licence to market Bt brinjal.
Safety issues have not been adequately dealt with both in terms of food safety and environmental safety. Long-term studies on allergicity and toxicity have not been carried out prior to approval.

We are also concerned about the implications for food security for the country. It is not desirable to hand over the control of seeds to transnational monopolies. To ensure that access to seed is ensured, the Intellectual Property Rights (IPR) regime must retain farmer’s rights and must not reduce flexibilities in Indian law.

As per the Cartagena protocol, to which India is a signatory, transgenic versions of crops for which we are the country of origin should not be permitted. Mexico, China and Peru follow this protocol. Thus transgenic varieties of Bt brinjal cannot be permitted in India.

A system of post-release monitoring must be put in place before commercial release is allowed into the environment to assess the performance and impact. Exhaustive socio-economic studies are necessary to assess the impact of transgenic crops on traditional agricultural systems and indigenous crops.

A proper system of labelling of GM crops must be put in place with public awareness to enable informed choices.

A system of public participation in decision- making and in regulatory bodies must be put in place. All regulatory data and bio-safety data should be available to the public.

A law of liability must also be in place before commercial release is permitted so that companies are liable to health and environmental damage that might ensue.

Till such systems are in place, this house calls for a moratorium on all transgenic crops.

The herbicide tolerant trait should not be permitted in India as this will displace agricultural labour and destroy valuable plants used as food, fodder and medicines.

There is indeed an acute agrarian crisis in the country. The solution to this does not lie in GM technologies. There are cheaper, safer, healthier options that must be explored and supported.
The participants included eminent experts like Dr Pushpa Bhargava, Founder Director, Centre for Cellular and Molecular Biology, Prof. Mohan Rao, Professor, CSMCH, JNU, Prof. Deepak Pental, Vice Chancellor, University of Delhi, Dr. Suman Sahai, Convener, Gene Campaign, Dr. Rama Baru, Professor, CSMCH, JNU, Dr N. Raghuram, School of Biotech, Guru Gobind Singh Indraprastha University, Dr K.C. Bansal, Professor, National Research Centre on Plant Biotech, IARI, Prof. K.J. Mukherjee, School of Biotechnology, JNU and Dunu Roy, Director, Hazards Centre.

The Colloquium was preceded by a letter sent by CSMCH to the Union Ministry of Environment and Forests. The resolution of the Colloquium would be sent to the Union Agriculture Ministry and Union Health Ministry shortly besides the Union Ministry of Environment and Forests. The program of the Colloquium is attached.

For Details: Dr. Mohan Rao, Professor, Centre of Social Medicine and Community Health, JNU
Phone: 26704490, E-mail:

Programme Schedule

0930 : Registration
10 00 : Inaugural Session

Welcome Address:
Prof. Mohan Rao, Professor, CSMCH, JNU
10 30 : Tea

10 45 – 12 00 hrs : Session I:
Benefits Claimed and Apparent Risks
Prof. Deepak Pental, Vice Chancellor, University of Delhi
Dr.Suman Sahai, Convener, Gene Campaign
12 00 – 13 30 : Session II :
Regulatory System and Concerns
Chair: Dr. Rama Baru, Professor, CSMCH, JNU.
Dr. K.Satyanarayana, Member of Exp Comm II, Genetic Engineering Approval Committee.
Dr. Pushpa Bhargava, Founder Director, Centre for Cellular and Molecular Biology
13 30- 14 30 : Lunch

14 30 – 16 00- Session III :
Need for Bt Brinjal
Chair : Dr. N.Raghuram, School of Biotech, Guru Gobind Singh Indraprasth University.
Dr. K.C. Bansal, Professor, National Research Centre on Plant Biotech, IARI.
Dr. G.V Ramanjaneyulu, Executive Director, Centre for Sustainable Agriculture
16 00- 16 30 – Tea
16 30- 17 30-

Concluding Session
Prof. K.J.Mukherjee, School of Biotechnology, JNU
Dunu Roy, Directror Hazards Centre
Vote of Thanks by Dr. Ramila Bisht, CSMCH, JNU

Note: Dr. G.V Ramanjaneyulu and Dr. K.Satyanarayana could not come for the program.

Bt Brinjal & Food Security

Center for Social Medicine & Community Health of JNU and Hazard Center organized a Colloquium on "Bt. Brinjal & Food Security" today at Jawaharlal Nehru University (JNU), New Delhi. Speakers underlined the inter linkage between food safety and security. Proceedings of the Colloquium would be shared in due course.

Earlier, responding to the introduction of Bt Brinjal in the country for public discussion by Jairam Ramesh, the Union Environment Minister, the Centre of Social Medicine and Community Health (CSMCH), Jawaharlal Nehru University had sent a letter to the Union Minister saying, “We believe that there are serious issues of safety that are not yet addressed through long term studies. There is some data that these crops could be allergy- inducing, and indeed that they might be mutagenic. It is for these reasons that in the European Union but major countries have a restrictive regulatory regime. Countries in EU have a precautionary approach towards GM crops and major countries like Germany, France, Hungary, Greece etc has a ban on their cultivation.”

CSMCH took cognizance of the reports suggesting that the Genetic Engineering Approval Committee (GEAC) has decided to approve the environmental release of Bt Brinjal from Monsanto/Mahyco in India which would for all purposes permit the use of transgenic and Genetically Modified Organisms (GMOs) and products for edible purposes.

The letter notes that CSMCH is seriously troubled with this move. The letter says, “ First of all, this is entirely unnecessary from a public health perspective, indeed undesirable. The argument that Bt brinjal would not require pesticides is dissembling. There are other, better, pest management methods like non pesticidal management that we need to utilize.”

It refers to “serious methodological flaws in the studies that have been carried out, not to mention ethical ones.”

It takes note of the “profound conflict of interest issues involved in the studies carried out in India. The companies that stand to gain by the introduction of these crops into the market were the sponsors of the studies. This is entirely unacceptable.”

The Prof Mohan Rao, Chairperson, CSMCH says, “There has not been adequate assessment of the ecological consequences of the introduction of this food crop. These concerns regarding the health and environmental risks associated with GM crops are too serious to be disregarded. Given our retailing structure, labeling is impossible in India and contamination is inevitable. Introduction of GM crops would kill the choice of the consumer."

The letter concludes saying that “this policy move is entirely unnecessary, has not been transparent and is potentially injurious to public health. We believe there should be a moratorium on such technologies till their safety both to human beings and the environment is proven.”