INDIA: Drug Firms Push Unapproved Fertility Drugs – Activists

By Ranjit Devraj Reprint | | Print |

Ranjit Devraj

NEW DELHI, Dec 30 2003 (IPS) - Lax drug regulations in India are allowing drug companies to push unapproved fertility drugs and to sneak in banned contraceptives that pose risks to women’s health, activists here say.

Lax drug regulations in India are allowing drug companies to push unapproved fertility drugs and to sneak in banned contraceptives that pose risks to women’s health, activists here say.

”There is very little real regulation or transparency when it comes to drug approvals and pharmaceutical companies are being allowed to play around with women’s bodies,” said Sarojini (one name) of the Sama Health Forum.

Sarojini and other activists recently made the shocking revelation that the anti-malarial drug Quinacrine, banned for use as a contraceptive in 1998, has resurfaced in several parts of India through private practitioners.

”Quinacrine is not being distributed through the public health system but through private practitioners and quacks,” she said. ”But the point is that these pellets are being distributed through a well-organised network and the Drug Controller of India (DCI) is not doing anything about it.”

Activists also had to raise their voices in protest before the government promised to investigate the systematic use of the anti-cancer drug Letrozole as a pro-fertility drug. Its use as such has not been approved by the DCI.

”We are examining the reports from the voluntary agencies – this is a serious matter,” an official in India’s health ministry said in an interview.

Last week, Health Minister Sushma Swaraj announced that the Mumbai-based, SUN Pharmaceuticals and Dabur (India) Ltd have been served ”serious warnings” to refrain from promoting Letrozole pending its approval for use as a fertility drug.

”We have asked them to destroy all relevant promotional material claiming its use in unapproved indications,” Swaraj said.

Letrozole, an original invention of the transnational Novartis, has been approved in India for treating breast cancer. But doctors have been found taking advantage of its ovulation-inducing properties to use it to improve fertility in women.

Several doctors working in private clinics have even acknowledged publicly that they have tested the drugs on infertile women – and were encouraged to do so by representatives from the two Indian pharmaceutical companies. The doctors, who asked not to be named for fear of legal action, said they were unaware of legal implications and merely followed drug protocols provided by the drug companies ”in good faith”.

At least 400 women are believed to have used the drugs on a trial basis by the doctors.

These ”research findings” have been circulated by the drug companies at medical conferences as part of promotion material that the government has now ordered destroyed.

No notice of the misuse of Letrazole and the illegal clinical trials were taken until they were brought to public notice by an editorial in the independent and well-respected ‘Monthly Index of Medical Specialities’ (MIMS) in its September edition.

”Some Indian companies have promoted an expensive anti-cancer agent – Letrozole – illegally to gynaecologists for ‘improving’ fertility in females,” its editorial said.

”The drug is acknowledged to be toxic to embryo and foetus by the original discoverer and drug regulators around the world, including the U.S. Food and Drug Administration (USFDA), the British Medicines and Healthcare Products Regulatory Agency (MHRA) and Australian Therapeutic Goods Administration (TGA),” it added.

”The government should have initiated legal action against the pharma companies and the doctors who took part in the trials,” Chandra Gulhati, the editor of MIMS and a former drug consultant with the World Health Organisation, told IPS.

Gulhati said the Letrazole case indicated the ease with which pharmaceutical companies flout drug laws in this country. ”It is clearly unethical for doctors to prescribe this drug for infertility.”

What is of concern to health activists like Navsharan Singh is that dangerous drugs are being used on women who are never told of its side effects.

For instance, Singh said that Quinacrine continued to be used after its ban in 1998 because ”there are no real consequences for those who ignore the ban, not even having to pay fines”.

Singh’s group, which interviewed 32 women sterilised with Quincarine, found that victims were completely unaware that the method had been banned and had serious health hazards.

”In fact, the providers assured the women that the procedure was safe and that there would not be any problems,” she said.