This article is written by Aastha Verma, pursuing B.A.LL.B from Kalinga University, Raipur, Chhattisgarh. The article describes the provisions of the various laws which prohibit pharmaceutical advertising in India with its exceptions.
Drugs play a very important role in the management of ailment and illness in human life. Medical practitioners are given a responsibility to prescribe various drugs according to the requirements of the individuals. However, various pharmaceutical companies indulge in advertising about medicine and medical devices and create doubt about the legality of these advertisements. They advertise through newspapers and television which misleads the general public and due to false beliefs, they start spending their time and money and thereby cause harm to themselves. Therefore, the government is concerned about the unethical marketing of medicines and medical devices. Thus, to protect the people from being exploited, the government has introduced various acts that prohibit such illegal activities. While the prohibition on promoting healthcare professionals are in place, there are some general guidelines that advertisers need to follow, else, they would be held responsible. The pricing of medicine is decided by the Drug Price Control Order, 2013 and National Pharmaceutical Pricing Authority has the authority to fix the ceiling price after which the importers cannot increase the price more than the Maximum Retail Price (MRP). The Ministry of Health and Family Welfare is also trying to introduce online portals for the sale and supply of medicines. Here, the article has mentioned the various acts in detail.
Advertisement of drugs
Advertisement of various drugs is very common in electronic media. Pharmaceutical companies are still doubtful about the legality of these advertisements. Various acts are made related to the regulation of the drug laws in India. The promotion of medicinal products in India is regulated by Drug and Magic (Objectionable Advertisement) Act, 1954 (DMRA). The Act prohibits the advertisement of drugs that suggests or leads to the use of drugs for the diagnosis or the prevention of the disease or conditions specified in the schedule. Originally the schedule contained 54 diseases. In a recently amended DMR Act, the list of diseases was expanded to 78. It will also apply to the AYUSH (Ayurvedic, Yoga and Naturopathy, Unanni, Siddha, and Homeopathy) drug makers.
Section 3 of the Drug and Magic Remedies (Objectionable Advertisement) Act, 1954 (DMRA) prohibits the advertisements of certain drugs for the treatment of specific diseases and disorders. The Schedule of DMRA provides a list of diseases whose advertisement is strictly prohibited. The Section prohibits the advertisement which is related to-
- the procurement of miscarriage of women or prevention of conception in women, or
- the maintenance of the capacity of human beings for sexual pleasure, or
- the correction of menstrual disorder in women and girls, or
- any of the diagnoses of any such disease or condition specified in the schedule.
Section 4 of DMRA prohibits the misleading advertisement of drugs if they directly or indirectly give a false impression related to the drug, make a false claim of the drug, or are false or misleading in any material particular.
Section 5 of DMRA prohibits the advertisement of magic remedies for the treatment of the diseases enlisted under the schedule.
Section 7 of DMRA provides punishment to the persons who contravene the provisions of the act. In case of the first conviction, the person will be liable for imprisonment which may extend up to six months or a fine, or both. In the case of a subsequent conviction, he could be imprisoned for a term which may extend up to one year, or be charged a fine, or both.
Section 10 of DMRA provides the jurisdiction to try the offence punishable under the Act to which the Judicial Magistrate of the first class will look at the case.
DMRA does not prohibit advertisement but it should be allowed with respect to certain types of drugs by various notifications by the Minister of Health and Family Welfare. The Central Government notified that the provision of Section 3(a) of DMRA is related to the prevention of conception in women and Section 6 does not apply to any advertisement related to the contraceptive and should be approved by the government.
Section 14 of DMRA permits the kind of advertisement in the following –
- Any sign board or notice displayed by the registered medical practitioner on his premises indicating the treatment for any disease, disorder, or condition specified in Section 3 of the Act.
- Advertisement relating to drugs sent to registered medical practitioners confidentially.
- Advertisement of drugs publically by taking the prior permission from the government.
- Any treaties or books dealing with diseases from a bona fide scientific or social standpoint.
Uniform Code of Pharmaceutical Marketing Practices (UCPMP Code)
The Code prohibits any inducement of healthcare professionals to prescribe, sell, supply, or recommend the use of particular medicines and by the notification from the Ministry of Home and Family Welfare, these restrictions apply to medical devices as well. It is also applicable to medical devices. Further, the Code prohibits pharmaceutical companies from extending the healthcare profession to any travel facilities inside and outside the country. Additionally, the standard Indian laws against corruption and bribery will apply in the event of a violation of these laws, and the culprit can also be prosecuted under the penal laws of India.
The DMRA defines advertisement under Section 2(a) of the Act as ‘any notice, circular, label, or other documents’ and ‘any announcement orally or by means of producing or transmitting light or sound or smoke’. These regulations are also applicable in online advertisements. Another recent development in this regard has been introduced by the Ministry of Family and Health Welfare, the draft of DMRA (Amendment) Bill, 2020, which aims to include online advertisement under the definition of advertisement.
Online supply of drugs
There is no Indian law that regulates the online sale and supply of medicine and medical devices. The Ministry of Health and Family Welfare has issued a draft notification to amend the Drugs and Cosmetic Act, 1940 to regulate the online sale of drugs, which has to be approved by the government. The draft notification prescribes a procedure for e-pharmacy registration, for the sale and distribution of drugs through the e-pharmacy portal.
Pricing of drugs
The pricing of medicine in India is controlled by the Drug (Price Control) Order 2013 (DPCO). The pricing obligations under DPCO apply to the importers, manufacturers, and marketers of the medicine and its device. The obligations are as follows –
- The Maximum Retail Price (MRP) of the product must not be increased by more than 10% within the 12 periods of time duration.
- If the importer or distributor increases the MRP of the product by more than 10%, he shall be liable for the overcharged amount along with the penalty and interest from the date of the price increase.
- All importers and distributors have to submit the price revision of the product to the dealers, hospitals, and government in Form V prescribed under DPCO.
- The National Pharmaceutical Pricing Authority (NPPA) has the authority to fix the price of the medicine and the medical devices under extraordinary circumstances, for the welfare of the public at large.
- After the price is fixed by the authority, the importers or manufacturers have to fix the MRP which will be equal to or below the ceiling price.
- The ceiling price of the medicine and the medical devices listed in the national list of essential medicines is fixed by NPPA.
Note – India does not have a mechanism for the reimbursement of drugs.
Advertisement for Ayurvedic drugs
The Drugs and Cosmetic Rules, 1945 provides for the advertisement of Ayurveda products and holds that under Rule 170, advertisement of AYUSH is strictly prohibited unless a unique identification number is obtained from a proper licensing body. In the case of Amit Singh Anr. v. State (2011), the Delhi High Court held that an attempt to bring the new innovative technology to the notice of the public can in no manner be termed as an advertisement to the sale and use of any particular drug.
Pharmaceutical marketing practices
The Organization of Pharmaceutical Producers of India (OPPI) is a non-governmental scientific organization that is an active member of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The OPPI provides guidelines for pharmaceutical marketing which is based on the IFPMA Code Pharmaceutical Marketing Practices. It provides good guiding principles which may be followed for better marketing of medicine and medical devices. OPPI Code also provides for the requirement of information contained in the advertisement of medicines.
In the case of Hamdard Dawakhana v. Union of India (1959), the Supreme Court held that the main purpose of DMRA is to prevent people from self-medicating concerning various diseases. Self-medicating in cases of serious diseases may lead to deleterious effects on the health of individuals and affect their well-being. Some people tend to induce others to restore to self-medication, through advertisements. Therefore it is necessary to have a complete check and compel manufacturers to route their products through recognized sources and test them properly. Thus advertisements should be done in the interest of public health. The Supreme Court further held that DMRA does not only prohibit the advertisement of drugs and medicines but also covers all the advertisements which are objectionable and unethical and promote self-medication or self-treatment.
The Supreme Court held Section 8 to be unconstitutional, and a portion of Section 3(d) of the DMRA was amended.
In the case of Sablok Clinic v. The State of Delhi (1984), the Sablok clinic had advertised that they prescribe medicines that could increase the sexual capacity of the users. The Sablok clinic pointed out that the complaint was filed after the period of limitation prescribed by Section 468 of the Code of Criminal Procedure (CrPC), 1973. The Court could not take cognizance of the offence after the expiry of one year. A notice was directed by the trial court in pursuance of the complaint to Sablok clinic. None of the doctors replied to the notice for more than a year, and thereby, the complaint was barred by time. The petition was allowed and the proceeding against the respondent was canceled.
In Cipla Ltd v. State of Tamil Nadu (2019), the Madras High Court resolved the query about the advertisement of ‘Ek Pill’, an emergency contraceptive, by stating that the petitioners were granted prior permission by the Drugs Controller General of India (DCGI), which was later rescinded. However, the High Court held that since on the day of advertisement, the permission of DCGI was in effect, the petitioners were not under default under the DMRA.
In the case of Mahesh Ramnath Sonawane v. Union of India (2014), the Supreme Court clarified the scope of drugs under DMRA and held that the definition of a drug under Section 2(b) of the Drug and Cosmetic Act, 1940 was found to be inclusive with a broad scope. It is not limited to a single type of medicine or medical device. Marketing of any substance cannot be used to promote self-medication.
It is common practice in India for pharmaceutical companies to advertise their area of business, infrastructure, research capability, etc. The Drugs and Magical Remedies Act was brought in force to control the advertisement of drugs, aiming to prohibit self-medication. By analyzing the various acts and rules, it could be concluded that the advertisement of all drugs is prohibited unless permitted by the Central government licensing authority, either by the law itself or by notification. These acts provide for the consistency of advertisements with the approved prescribing information, prohibition of certain types of advertisement, and penalties against the breach of the mandatory requirements.
- Pharmaceutical Advertisements in Indian Scientific Journals: Analysis of Completeness of Information Content (ijpsr.info)
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