Deceptive pill

In a strongly-worded letter dated January 29, copy of which has been marked to Gujral, Chowdhury has pointed out that HLL has been violating the 1995 guidelines issued by the Health Ministry to make a change in the composition of oral contraceptive pills. At that time, the Ministry’s official note on the subject stated that the change was being made, “taking into consideration the total dietintake of Indian women as well as the state of anemia amongst women…”

Subsequently, all the major manufacturers — HLL, IDPL, Eupharma and Pharmasia — were asked to include seven pills of ferrous fumerate along with 21 pills of hormones in the packs of Mala D and Mala N. While Mala D is sold at subsidised rates in the open market, Mala N is meant for free supply in Public Health Centres.

A few days after she raised the matter, Chowdhury told The Indian Express that the failure of HLL to change their composition was a serious lapse. “The Health Ministry had asked for the iron supplements keeping in mind the high percentage of women with anemia,” she said. “By ignoring the directive and putting sub-standard contraceptive pills in the market, HLL has further endangered the health of women.”

As a result of her objections, the Health Ministry wrote to HLL asking them to immediately replace the seven pills with placebos (dummy pills made of inert substance) with ferrous fumerate. The letter,sent by the Ministry’s sales promotion department on January 21, states that while other manufacturers had followed the Ministry’s guidelines, only HLL had failed to do so.

The letter points out that the sale of the contraceptive pills in two different compositions can pose a problem since “the customer will prefer Mala D containing ferrous fumerate tablets and stockists can object to the supply of Mala D with the old composition”. HLL has now been warned that in case the required drug licenses were not obtained, placement of fresh orders with them would be stopped.

HLL, it appears, was galavanised into action once the controversy over the composition of Mala D and Mala N erupted. HLL’s Chairman and Managing Director, G. Rajamohan admits that they have been late in adding ferrous fumerate but clarifies that the delay was on account of the Karnataka Drug Controller holding up the license on some pretext or the other.

Rajamohan says HLL has now obtained license for test manufacture of the ferrousfumerate pills and expects to get the license for final production any day now. “We have not committed an offence by not supplying the iron,” he asserts. “The quality of the pills has not been effected and when the next batch of 7.5 lakh cycles goes out, it will contain the ferrous fumerate.”

Despite such assurances, Renuka Chowdhury is determined to take up the matter with the Prime Minister again — notwithstanding the fact that her tenure as Health Minister is drawing to a close. She said she has also complained about an incident when bureaucrats gave HLL an order for 75 lakh cycles even as the main file for orders for 300-odd lakh cycles (for two months supply) was pending with her.

While pointing out this anomaly, too, Chowdhury questioned how HLL was allowed to sell the contraceptive pills without the ferrous fumerate. In a note dated January 29, she has asked that if the Ministry was told the company would be shortly getting the license, why couldn’t the order wait? “Why has the HLL beenallowed to get away with all this since 1996?” she has demanded on file.

Curiously, the replies given by Ministry officials to Chowdhury, negate the very concept of introducing iron supplements in Mala D and Mala N.

In a reply marked to Chowdhury, the officials have said while the change was made taking into account the low iron intake of women, the prescribed quantity of iron (60 mg) was not sufficient therapeutic dose. Hence, they have told her, there is “no difference” in the effect of oral contraceptive pills supplied earlier with placebos or those with ferrous fumerate.