While the Kerala Drug Controller warned the public and doctors in the state against the misuse of anti-breast cancer drug letrozole as an infertility drug, the state branch of the Indian Medical Association (IMA) has questioned the DCs move stating it as an infringement into their duties.

A press release from the drug controller this week said that the department noticed many doctors and drug manufacturers promoting letrozole as an anti-infertility drug. The drug was approved only for usage against cancer.

A leading daily in Kerala recently published a series of articles on the rampant usage of Letrozole as an anti-fertility drug in major cities and towns in the state. The DC's release was to alert the public on the matter, senior drug officials told Pharmabiz.

Quoting some of the doctors in the state, the paper had said letrozole was being experimented in the state for treating infertility in the cities of Kottayam, Pathanamthitta, Thiruvananthapuram, Kozhikkode etc. The report even quoted a gynaecologist from Kannur Pariyaram Medical College saying that 'many patients were discarding letrozole's usage as it was found ineffective in the treatment of infertility."

Defending the doctors who used the drug for infertility, the state office bearers of IMA said the drug control office has no powers to decide on the treatment side of a drug, as it was up to the doctors to decide.

"It is up to the drug control department to decide which drug can be used for a disease. If they find letrozole good for infertility, the manufacturer should get approval for a new drug. As of now, it is only an anti-cancer drug. The doctor can only follow the information given by the manufacturer in accordance to our approval. We have not authorized anyone to conduct experiments unknowingly on patients" reacted a senior drug official in Kerala.

Sources opined the issue demands threadbare discussion on the ethical and moral stand of the doctors. "This issue clearly shows lack of a Medical Practitioner's Act in the state to enforce some kind of monitoring or regulatory mechanism on practitioners of medicines. Now the doctors have to adhere to a code of conduct, which is a moral obligation. They are immune to drug laws. However, does that mean they have liberty to experiment any drug on people in liaison with the manufacturer, who may be paying for that service?" asked a drug enforcement officer.

Sources pointed out that it was a common practice among many doctors to use certain drugs meant for a particular treatment to treat for some other disease, if found effective. "Majority of the doctors read only the scientific literature on medicines, not the happenings in trade or manufacturing. If the doctors conducted Letrozole trials with the knowledge that the drug may cause severe side effects and is an unapproved drug, they should be accountable for it", felt another official.