The move – if approved by the drug controller general of India (DCGI) – will relax the labelling requirements for weekly oral contraceptive drug, centchroman, and a daily contraceptive drug combination of ethinyloestradiol and levonorgestrel
A top panel of experts has cleared the proposal to simplify the sale of oral contraceptive pills in a move that will enhance access and resolve confusion over two contradictory rules.
The move – if approved by the drug controller general of India (DCGI) – will relax the labelling requirements for weekly oral contraceptive drug, centchroman, and a daily contraceptive drug combination of ethinyloestradiol and levonorgestrel.
The Drug Technical Advisory Board (DTAB) deliberated over the proposal in its meeting in August and submitted it for approval with DCGI.
So far, these drugs fell under Schedule H and Schedule K, but the two schedules completely contradict the sales requirements. On the one hand, the “finished formulation of the drug centchroman and drug ethinyloestradiol” falls under Schedule H, however, the drug with a combination of levonorgestrel (0.15 mg) and ethinyloestradiol (0.03 mg), drug centchroman of 30 mg falls under the schedule K of the Drugs Rules, 1945.
Now, these two schedules contradict each other as chemists or e-pharmacies cannot dispense Schedule H drugs without a prescription, whereas the drug under Schedule K is for over-the-counter (OTC) sales. Schedule H follows strict labelling requirements on the pack of medicines stating ‘Not to be sold by retail without the prescription of a Registered Medical Practitioner.’ As dispensation under Schedule H without a prescription is considered an offence, pharmacists refrain from selling drugs without a prescription, hence Schedule K becomes invalid. This makes the Union Health Ministry’s purpose of promotion of family planning tools futile.
However, the panel has now decided to align and bring clarity as there are many other hindrances in Schedule H such as the promotion and advertisement of these drugs for awareness campaigns and educating women on their usage. Not only in towns, but the need for prescription to buy oral contraceptives will damage the objective of family planning drives in the rural and remote pockets of India.
WHAT DID THE PANEL DELIBERATE ON?
In the latest meeting of DTAB held in August, the document says, “it was proposed to make the certain amendments under Drugs Rules, 1945 to avoid contradiction in the labelling of products namely Levonorgestrel-0.15 mg + Ethinyloestradiol- 0.03 mg and Centchroman-30 mg”.
It concluded that “DTAB deliberated the matter and agreed for the dose-specific amendment in Schedule H under Drugs Rules, 1945.”
The panel has been deliberating on the matter for the last many meetings. According to previous minutes of the meetings of DTAB, the panel had received representation from the government public sector unit, HLL Lifecare Limited. The firm had earlier requested the panel to remove the requirement of Schedule H on these oral contraceptive drugs.
HLL had told the panel that “the company is manufacturing and supplying regular oral contraceptive pills to the Ministry of Health and Family Welfare under National Family Welfare Programme since 1993 under various brand names of contraceptive like Mala N, Mala D, Apsara, Choice, Ecroz, Khushi, Sunheri etc. containing drug composition Levonorgestrol I.P. 0.15 mg. Ethinyloestradiol I.P. 0.03 mg…”
The firm said that it has submitted that labelling of the above products was initially done by mentioning ‘Schedule K’ on all packing material. However, objections were raised by one of the state drugs controller office on the labelling of these products.
HLL was asked to follow Schedule H requirements which include printing of Rx, red box and Schedule H warning in the primary and secondary packages of the products. While the company followed Schedule H requirements in its packing artwork, it continued to face difficulties in selling and supplying these products under various schemes of the Union Health Ministry.
HOW DOES SCHEDULE H HINDER THE SUPPLY OF ORAL CONTRACEPTIVES?
Some of the challenges, HLL mentioned in the presentation, include Schedule H drug cannot be advertised, which is very essential for social marketing to educate people about proper use of the product. Also, Schedule H drug can only be sold with a prescription of a registered medical practitioner whereas social marketing products are meant for providing affordable contraceptive in the remotest area of the country where availability of registered medical practitioners is a constraint.
“The selling of Schedule H drugs requires proper retail licence for selling medicines which is not possible for social marketing organizations, as their products are sold under government schemes through over-the-counter (OTC) and not through prescription,” HLL had said in the representation.
ORAL CONTRACEPTIVE PILLS IMPORTANT PART OF GOVERNMENT HEALTH PROGRAMMES
It’s important to keep oral contraceptives accessible to women which has also remained one of the important pillars of Union Health Ministry’s family planning agenda. The government via the National Family Planning Program promotes the use of oral contraceptives stating that they are safe, effective and reversible methods to prevent pregnancy.
“Oral contraceptive methods, both hormonal and non-hormonal offer women option of delaying, spacing and limiting the birth of children. Tightening the rules around these medicines will impact negatively as it would lead to an increase in cases of abortions and termination of pregnancies,” said Dr Ruby Sehra, unit head and senior consultant, gynaecology and obstetrics, New Delhi-based Sri Balaji Action Medical Institute.
