MINISTRY OF AYUSH NOTIFICATION, New Delhi, Dated 21st December 2018
Drugs and Cosmetics (Eleventh Amendment) Rules,2018. After Rule 169, in the Drugs and Cosmetics Rules the following Rule shall be inserted.
170 Prohibition of Advertisements of Ayurveda, Siddha or Unani (ASU) drugs
- The manufacturer or his agent, of ASU drugs, shall not participate in the publication of any advertisement relating to any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition.
- The ASU drug shall be advertised for the purpose other than specified in sub-rule (1) after the allotment of the Unique Identification Number (UIN)
- The manufacturer of the ASU 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 (by 21-03-19).
- The application for 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 ASU drug in terns which suggest or calculated to lead to the use of that drug or medicine for the enhancement of height and dimensions or capacity of the 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 ASU drug or
- it makes a misleading or exaggerated claim about the effectiveness of the said drug.
- The application for allotment of the Unique Identification Number for an advertisement shall be submitted in Form 26 E-4 to the State Licensing Authority or Drug Controller specifying therein the claims such as textual references, rationale from the authoritative books, indications) or uses evidence regarding safety, effectiveness, and quality of the drug.
- The application fee of rupees one thousand per advertisement shall be deposited along with Form 265-4 and other supporting documents.
- The application for the advertisement shall be submitted to the Licensing Authority of the State where the corporate office of the manufacturer is located, in case the ASU drug is licensed for manufacturing in more than one State
- The State Licensing Authority shall process the application (if required, in consultation with the concerned technical experts) for disposal within thirty days from the date of receipt of application along with complete information and shall allot UIN for the advertisement
- The manufacturer of ASU drug may appeal to the State AYUSH or Health Secretary for the direction in case the application for allotment of UIN under sub-Rule (8) is not disposed within the period of 30 days.
- The applicant shall furnish the required information to the Licensing Authority or Drugs Controller as and when called for, failing which the application shall be rejected and the application fee shall stand forfeited.
- The State Licensing Authority or Drugs Controller on being satisfied with the application or otherwise shall record and convey in Form 26 F-5 the recorded contents of the advertisement, reasons for rejection of the application or any clarification required from the applicant.
- The advertisement recorded by the Licensing Authority or Drugs Controller in Form 26 E-5 shall be valid till the date of validity of the license to manufacture for sale of that drug and can be renewed thereafter
- An appeal may be filed before the Central Government against the decision of the State Licensing Authority under sub-rule (11) and the order of Central Government shall be final and binding on the appellant and the State Licensing Authority
- The State Government may notify in the Official Gazette 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 the 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 the quarterly basis and also as and when sought by the Central Government.
The State Licensing Authority may suspend or cancel the license of the manufacturer of the ASU drug as per the provisions of Rule 159, in case the directions given by the said authority has not complied
The Central Government shall, in the public interest, prohibit any advertisement of the ASU drugs, by notification in the Official Gazette in Schedule A, after Form 26 E3, the following Forms shall be inserted, namely: FORM 26 E4 (Application Form for Advertisement) and FORM 26E5 (Permission granted by the State Licensing Authority of the State/UT).
NOTE
The Application in Form 26E4 (with the details like name of the drug, Contents of the Advertisement, Reference of indications, Language of advertisement and Medium of Advertisement) for each Advertisement shall be submitted along with the following
A Treasury chalan for Rs 1000/-
Valid Drugs Manufacturing Licence
References of Indications/Claims, (such as textual references, rationale from official books)
Proof of Safety
Proof of effectiveness
Quality Standards
Copy of the Picture/Audio/Video for Advt in print /electronic /internet /audiovisual media
The SLA after processing the Application shall allow a UIN within 30 days of receipt of the completed application. The SLA shall maintain printed register as well as an online register of the Advertisements with appropriate entries for regular monitoring of them. The permission for advertisement in FORM 26E5 is valid till the validity of the current Manufacturing Licence of the drug and can be renewed thereafter.
The permission granted shall not be reflected or shown in the Advertisement in any form.
