New Delhi, Nov. 18: Indias drug regulators approved a vaginal contraceptive ring developed in a foreign country without any clinical trials on volunteers from India, company executives, drug regulators and independent experts said today.
Organon, a global pharmaceutical company, announced the launch in India of its vaginal ring that contains the same hormones found in the oral pill, but is to be self-inserted only once-a-month for contraceptive action. Company officials said the ring, approved by the US Food and Drug Administration in 2001, was currently used in more than 42 countries.
The Central Drugs Control Standards Organisation (CDSCO) in New Delhi approved the contraceptive ring for marketing in India in 2005 on the basis of data from clinical studies of the product outside India, company officials told The Telegraph.
We have all regulatory approvals for this, a senior official said.
Some doctors have hailed the ring as a significant advance in contraception, saying it combines the 99 per cent efficacy of the daily oral pill with the ease of once-a-month self-insertion by a woman. The product costs about Rs 790 each.
Women sometimes forget to take the pill, a senior gynaecologist from a private institution present at the launch said. This ring is inserted for a three-week period after which it is removed for a one-week ring-free period.
But under laws governing approval of drugs in India, products already in use outside the country need to go through Phase-3 trials — a process during which the product is offered to about 100 volunteers at three to five medical centres as a test of efficacy in the Indian population.
Although the product has the same hormones that are found in a pill, under section 122E of the drugs and cosmetics act, a change in the route of administration is to be viewed as a new drug, said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, an independent journal of drugs.
The absence of a clinical trial would make this approval (by the CDSCO) unethical and illegal, Gulhati said.
The CDSCO had sent all the available product data to the Indian Council of Medical Research, which recommended that a fresh clinical trial in India was unnecessary, a senior drug regulator in New Delhi said.
As a rule, clinical trials are required for all products —but there are three exception clauses, the regulator said, speaking on condition of anonymity. We can relax the clinical trial rule when there is a life-threatening condition, when there is a public health emergency, or the product involves an illness with special relevance to the Indian health scenario, the official said.
In this case, the Indian Council of Medical Research examined the post-marketing surveillance data from other countries and recommended that there was no need for another trial, the regulator said.
The hormones in the pill are associated with increased risk of several side effects, including blood clots that may lead to a stroke or a heart attack. The vaginal ring is therefore unsuitable for women with a history of these conditions, the company said.