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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 Parliamentary Standing Committee on Ministry of Chemicals and Fertilizers has made a recommendation to the country’s drug price regulation authority (the National Pharmaceutical Pricing Authority), to install and implement the Price Monitoring and Resource Units in all of States and Union Territories where they have not yet been set-up.
Source: bit.ly/4hBFqB8

2. The State Consumer Redressal Commission of the state of Delhi recently held that the obligation of a treating doctor to attend to a patient during an emergency situation, should supersede and mitigate his liability against any claim of negligence that may be levelled against him for his failure to refer the patient to a concerned specialist where such specialized treatment may be deemed necessary but for the emergency situation.
Source: bit.ly/4jAMHTG

3. India’s foreign trade regulator, the Directorate General of Foreign Trade has issued a Notification instructing Regional Authorities (Ras) to reduce the Export Obligations of exporters in sectors that have experienced a decline of more than 5% in volume. This now includes, among other product categories the export of Radioactive Isotopes from India.
Source: bit.ly/42zKAcB

4. India’s foreign trade regulator, the Directorate General of Foreign Trade has altered the procedure for obtaining a Certificate of Origin (CoO) by exporters. Notably, the Export Inspection Council (EIC) has been stripped of its previous authority to provide and print blank CoOs, and applicants will also now be required to make their applications on the online platform.
Source: bit.ly/4hALDxj
Source: bit.ly/3EpEjGm

5. The Parliamentary Standing Committee on Ministry of Chemicals and Fertilisers has recommended in its recent report, that various State Licensing Authorities should be sensitized on the best practices and procedures for the issue of license for Class A & B Medical Devices.
Source: bit.ly/4az0Lch

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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.