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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s central food authority (FSSAI) has extended the enforcement date for the amended labelling requirements under the Alcoholic Beverages Regulations, 2025. The earlier deadline of 1 January 2026 is now postponed to 1 July 2026. The decision follows stakeholder concerns that mid-year labelling changes would disrupt operations, cause wastage of pre-printed labels, and create additional costs, especially due to State Excise label-registration cycles.
Source: h7.cl/1kc0S

2. India is reportedly negotiating mutual recognition agreements (MRAs) with major partners such as the US, EU, UK, Singapore and ASEAN to align inspection and testing systems. The aim is to cut rejections, ease trade friction and streamline exports of basmati rice, spices, tea, coffee, marine products, fruits and vegetables, improving global competitiveness.
Source: h7.cl/1flqZ

3. India’s central food authority (FSSAI) has issued amendments to the FSS (Alcoholic Beverages) Regulations, 2018 wherein the permissible maximum level of ethyl acetate esters in alcoholic beverages has been increase from “0.2” g/l to “3.0” g/l.
Source: h7.cl/1kc16

4. India’s Drugs Consultative Committee has agreed to add levonorgestrel tablets in 0.75 mg and 1.5 mg widely known as morning-after pills to Schedule K, enabling continued OTC sales. This also includes provisions for a boxed warning on packaging highlighting side effects, no protection against HIV/STIs, limits on use, and recommendations for consulting practitioners on alternatives.
Source: h7.cl/1kbV8

5. The Supreme Court of India has reportedly directed Noida District Hospital to constitute a primary medical board within two weeks to assess passive euthanasia for a 31-year-old man who has been quadriplegic and in a vegetative state for more than a decade.
Source: h7.cl/1flra

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. In its recent annual Budget announcement, the central government has proposed to waive customs tariffs on three additional drugs, used in treatment of cancer.
Source: bit.ly/4dinoSC

2. The Bombay High Court held a Director of a chemical manufacturer criminally liable for export of controlled substances from the country, holding that all officers of companies should keep themselves abreast of the latest regulations, and being ignorant of new notified compliance cannot excuse liability.
Source: bit.ly/46iRp22

3. The Madras High Court stayed a suspension order issued against a branch of a major fast food chain, holding that suspension cannot be ordered without giving an opportunity to improve its practices in pursuance of an Improvement Notice issued under Sec. 32(1) of the Food Safety Standards Act, 2006.
Source: bit.ly/3LFGne4

4. The Ethics and Medical Registration Board of the National Medical Commission of India, the country’s premier regulator of the medical profession has recently issued a decision proposing to expand the scope of qualified Doctors that may now be permitted to undertake spinal surgery. While previously only neurology specialists were permitted to operate on the spine, orthopedic specialists may also undertake the same with existing qualifications.
Source: bit.ly/46s1oCn

5. An appeals courts of the United States has rejected the petition of several US states against the reclassification of contraceptive medication, holding that no grounds were established to prove actual harm suffered by the State governments. as claimed.
Source: bit.ly/3zZpdFC

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Can Oral Contraceptive Pills be advertised in India?

Oral Contraceptive Pills (OCPs), also known as daily contraception pills or birth control pills are used to prevent pregnancy. However, these pills have their limitations and side effects. Given the use of OCPs, one would expect it to be widely advertised to the public in India. However, it is rare to come across an advertisement that freely advertises OCPs. Even, the label of such OCPs in itself does not indicate that it is intended to be used for the prevention of pregnancy in women after unprotected sex.

It is important to understand OCPs are different from Emergency Contraception Pills (ECPs). OCPs are taken regularly to prevent pregnancy. An ECP, on the other hand, contains a single active ingredient in high dosage and is taken once after unprotected sex to prevent pregnancy.

In this article, we have analysed the legal framework for the advertisement of OCPs in India and concluded that while there is a legal bar on the advertisement of OCPs, certain compositions and strengths of OCPs may be advertised.

Legal Framework for Advertisement of ECPs

There are two laws that regulate the advertisement of OCPs –the Drug Rules, 1945 (“Drugs Rules”) which bar the advertisement of prescription drugs, and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMRA”) which bar advertisement of a drug in terms which may suggest that it may be used for prevention of conception in women. However, both Drugs Rules and DMRA have certain exceptions, which we will discuss in the following paragraphs.

Exceptions under Drugs Rules for OCPs

There are certain compositions of OCPs that have been exempted from the requirement of being sold under a drug license, with the underlying intent there being that such compositions ought not be sold under a prescription of a registered medical practitioner (“Doctor”). We have reproduced the composition of these OCPs in the table below.

1. DL-Norgestrel-0.30 mg.
Ethinyloestradiol-0.03 mg.
2. Levonorgestrel-0.15 mg.
Ethinyloestradiol-0.03 mg.
3. Centchroman-30mg.
4. Desogestrel -0.150mg.
Ethinyloestradiol 0.030mg.
5. Levonorgestrel 0.1mg
Ethinyloestradiol 0.02mg

The above OCPs are clearly not prescription drugs, and therefore the bar on advertisement of prescription drugs would not apply to those OCPs.

Exception under the Drugs and Magic Remedies Act

The DMRA contains an enabling provisions through which the Central Government can restrict the scope of DMRA. In 1992, the Central Government notified a list of compositions of OCPs to which the restriction on advertisement under DMRA will not apply. We have reproduced the composition per tablet of these OCPs in the table below.

a. DL-Norgestrel- 0.30 mg.
Ethinyl Estradiol- 0.03 mg;
b. Levo-norgestrel- 0.15 mg.
Ethinyl Estradiol- 0.03 mg;
c. Centchroman- 30 mg.

Therefore, in so far as OCPs are concerned, only the below compositions of OCPs which are exempted under both Drug Rules and DMRA may be advertised in India, subject to certain basic compliance conditions and other informal guidance issued by Regulators from time to time.

1. DL-Norgestrel- 0.30 mg.
Ethinyl Estradiol- 0.03 mg;
2. Levo-norgestrel- 0.15 mg.
Ethinyl Estradiol- 0.03 mg;
3. Centchroman- 30 mg.

Past controversies

In 2008, a criminal complaint was filed against Cipla Ltd. and its Directors, a major pharmaceutical company, for the advertisement of contraception pill sold under the brand name ‘Ipill’, having a composition of Levonorgestrel IP-1.5 mg. In 2015, another criminal complaint was filed against Cipla Ltd. and its Directors, for the advertisement of another contraception pill having the same composition but bearing the brand name ‘EK Pill’. The grounds in both the complaints were the same, that Cipla Ltd. had violated DMRA by advertising contraception pill to indicate that it can prevent conception in women. Cipla filed a petition against the criminal complaints and prevailed in both the cases on grounds that it had been explicitly permitted by the Central Drugs Standards Control Organization (CDSCO) to advertise the drugs. It relied on a 1961 notification under DMRA, which allowed companies to advertise ECPs, provided they were approved by the Central Government (CDSCO).

Going forward

As indicated above, certain compositions of OCPs may be advertised. However, before advertising, it should be ensured that the advertisement meets the requirements of law and also guidelines that have been proposed by various authorities. For example, the advertisement should not be misleading. A violation of the law can result in criminal prosecution as well as cancellation of the manufacturing license.