The AYUSH Ministry has come up with stringent regulatory guidelines to prevent misleading and inappropriate advertisements of Ayurveda, Siddha and Unani (ASU) medications in the country. On December 21, 2018, the Central Government introduced the eleventh amendment of Drug and Cosmetic Rule, 2018, which addresses 'Prohibition of advertisements of Ayurveda, Siddha or Unani drugs' in public interest.
THE NEED FOR AMENDMENT
Till date Drugs and Cosmetics (D&C) Act, 1940, regulates the manufacturing, sale and distribution of ASU medicines under various provisions of Drugs and Cosmetic Rule, 1945, whereas, the Act which regulates the advertisement of prescription-only drugs such as Schedule H, H1 and X to the general public, has not specifically addressed the advertisement of ASU drugs.
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which regulates the advertisement of 'drug', covers all medicines, substances and articles other than food products. The Act empowers State Government to authorize Gazetted Officers to search, seize, examine any record, register, document or any other material object related to any objectionable advertisement, and analyze and monitor the veracity of misleading advertisements under the provisions of the Act.
At present 22 States have appointed 621 Gazetted officers to enforce the legal provisions for taking necessary actions against the defaulters. Ministry of AYUSH also signed a MoU with Advertising Standards Council of India (ASCI), a self-regulatory voluntary organization of advertising industry for suo-moto monitoring of misleading advertisements of AYUSH drugs appearing in the print media and TV channels and bring the defaulters to the notice of respective State regulators1.
Despite this, the increasing numbers of complaints of misleading advertisement of ASU drugs has been reported in Grievances against Misleading Advertisements (GAMA) portal, Ministry of Consumer Affairs, Food and Public Distribution. Therefore, the AYUSH Ministry, after consultation with the Ayurveda, Siddha and Unani Drugs Technical Advisory Board has introduced Rule 170 in the eleventh amendment of Drugs and Cosmetics Rules, 20182:
Rule 170: Prohibition of advertisements of Ayurveda, Siddha or Unani drugs
The rule restricts ASU drug manufacturers from advertising their products
The manufacturer of Ayurveda, Unani or Siddha shall not participate in the advertisement of any drugs relating to any drug or the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition.
The advertisement of ASU drugs shall be allowed with conditions
The Ayurveda, Siddha or Unani drug shall be advertised for the purpose other than restricted purpose after the allotment of the Unique Identification Number (UNN).
The manufacturer of the Ayurveda, Siddha or Unani drug shall apply for the Unique Identification Number for the advertisement issued or aired before this notification, within the period of three months from the date of the publication of this notification.
The application of advertisement shall be rejected if:
- It is incomplete; or
- the intended advertisement does not contain the contact details of the manufacturer; or
- the contents of the advertisement directly or indirectly tantamount to vulgarity or obscenity; or
- it refers to any Ayurvedic, Siddha or Unani drug in terms which suggest or calculated to lead to the use of that drug or medicine for the enhancement of height and dimensions or capacity of performance of male or female sexual organs; or
- it depicts photographs or testimonials of celebrities or government officials; or
- it refers to any Government or Autonomous organization of the Government; or
- it gives a false impression about the true character of Ayurvedic, Siddha or Unani drug; or
- it makes a misleading or exaggerated claim about the effectiveness of the said drug.
The application procedure for ASU advertisement
The application for the allotment of the unique identification number should be submitted in Form 26 E-4 plus application fee plus other supporting documents to the State Licensing Authority or Drug Controller. The state licensing authority shall process the application within 30 days from the date of receipt of application.
Monitoring misleading Advertisement of ASU drugs
The State Government may notify the officers of ASU system to undertake the monitoring of the advertisements of ASU drugs in the print, electronic, internet and audio-visual media and maintain printed register as well as online register of the advertisements with appropriate entries including those found inappropriate or invalid and action taken against such faulty advertisements and the State Government shall provide information of the advertisements to the Central Government on quarterly basis and also as and when sought by the Central Government.
Note - The Central Government shall, in the public interest, prohibit any advertisement of the Ayurveda, Siddha or Unani drugs, by notification in the Official Gazette.
The amendment provides very precise and clear guidelines to address advertisement of ASU medicines. The manufacturers of the ASU medicines have to abide by these rules and inclusion of the UNN number will play a pivot role in promoting authentic ASU products, and preventing defaulters from misleading public with false claim in their advertisement content.
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