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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. The Drugs Technical Advisory Board (DTAB) has approved a proposal to amend the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to eliminate the two-step certificate issuance process for biomedical and health research ethics committee registration. Now, a system for reviewing and examining all ethics committee documents has been put in place at Department of Health Research (DHR). This process allows for the removal of redundant work and resource use, and only final certificates can be directly issued to ethics committees.
Source: bit.ly/3A8haGQ

2. To improve India’s whole digital healthcare infrastructure, a new certification program for hospital information systems (HIS) and electronic medical records (EMR) has been introduced by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). The program offers Basic and Advanced maturity levels that are valid for two years. The NABH portal will open for registration on December 1, 2024.
Source: bit.ly/3UjzcN7

3. The Drugs Controller General of India (DCGI) plans to amend the Medical Devices Rules, 2017, to include quality control provisions for non-sterile, non-invasive Class A medical devices like thermometers and stethoscopes. Currently exempt from licensing, these devices will now require manufacturers to comply with a quality management system.
Source: bit.ly/3NApDpw

4. The Madras High Court has ruled that Siddha practitioners are permitted to practice modern medicine but are prohibited from storing allopathic drugs without a valid license under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4hs9VKT

5. The World Health Organization (WHO) has prepared a draft guideline for food packaging to include health impact labels on the front, emphasizing the need for clearer consumer information regarding potential health risks associated with food contact materials. The draft received public comments till October 11, 2024 and will release the final guidelines in 2025.
Source: bit.ly/3BQlKKm

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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.