After inserting a rule in the Drugs and Cosmetics Rules, 1945 to prevent inappropriate advertisements of Ayush medicines in 2018, the Ayush ministry has done an about-turn with its technical advisory board recommending that the rule be omitted. This is despite the fact that the government had consulted the same board before bringing in the rule. Moreover, in its meeting in June 2022, the board had recommended that omission of Rule 170 was not required.
According to the minutes of the last meeting of the Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) held on May 25, the board has recommended the omission of Rule 170, which was inserted into the Drugs and Cosmetics Rules, 1945 in December 2018. Rule 170 was meant to prohibit advertisement of Ayurvedic, Siddha and Unani drugs without the ad being cleared by the licensing authority of the state where the manufacturer of the medicine is located or where the corporate office is located, in case the manufacturing is happening in more than one state.
Rule 170 had been brought in through an amendment to the rules after consultations with ASUDTAB in response to an increasing number of misleading advertisements of Ayush products. Moreover, in a report sumitted in March 2018, the parliamentary standing committee on health pulled up the ayush ministry and the health ministry for not bringing in a law to tackle the rising menace of misleading Ayush ads. In 2018, the Ayush minister revealed that the ministry had come across 804 instances of misleading advertisements or claims between April 2015 and January 2018. Pharmacovigilance centres of Ayush reported 1,127 cases of misleading advertisements from August 2018 to March 2019. However, in less than a month after the new Rule 170 was gazetted, several manufacturers went to court against the rule and in January 2019 the Delhi high court stayed its operation.
The minutes of the May meeting of ASUDTAB noted that the Association of Manufacturers of Ayurvedic Medicines had given a representation in April 2023 seeking the repeal of Rule 170. Dr CK Katyar, an industry representative, informed the board that provisions for prohibition of misleading advertisements were covered under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Consumer Protection Act. Dr Asad Mueed, yet another industry representative, also argued that there was no requirement of Rule 170 as proper implementation of Drugs and Magic Remedies (OA) Act 1954 was sufficient and that restriction on awareness spreading initiatives of the industry will be against the government’s commitment for propagating Ayush systems.
“This is a clear case of misleading the board. Drugs and Magic Remedies Act or the Consumer Protection Act will apply only after a misleading ad has appeared. Hardly any action gets taken when such complaints are filed and the cases drag on for years, by which time the intent of publishing such an ad will be met. Rule 170 was meant to be preventive. It would have prevented misleading ads from being published as these ads would first have to be cleared by the concerned state licensing authority. It is unfortunate that the government is buying the industry argument instead of working to protect public interest,” argued Dr KV Babu, an ophthalmologist and RTI activist who has filed several complaints against misleading Ayush ads. This will open the floodgates to misleading Ayush advertisements to the detriment of people’s health, he added.
On May 1, 2023 the government submitted in court that the matter would “be placed before ASUDTAB for reconsideration”. It failed to mention that the matter had already been taken up by ASUDTAB in its meeting in March 15, 2021 after recommendation by an expert committee of the Ayush ministry and that the board in its next meeting in June 2022 had recommended that there was no requirement to omit Rule 170.
Timeline of the efforts to combat misleading Ayush ads
Jan 20, 2017- Ayush ministry signs MoU with Advertising Standards Council of India (ASCI) to monitor misleading AYUSH-related advertisements in print and TV media. In one year following the MoU, ASCI reported 732 instances of such misleading ads
Mar 13, 2018- Parliamentary Standing Committee on health in its report expresses concern about misleading ads for Ayush products and pushes for a new law to prohibit them
Dec 21, 2018- Central Government gazettes the eleventh amendment of the Drug and Cosmetic Rule, 2018, by inserting Rule 170, which stipulated that all Ayush ads need to be cleared by state licensing authority. The new rule is framed in consultation with the technical board, ASUDTAB
Jan 15, 2019- Many Ayush manufacturers go to court. Delhi High court stays operation of Rule 170
Mar 15, 2021- Decision of omitting Rule 170 is taken by ASUDTAB after recommendation by an expert committee of the Ayush ministry
Jun 27, 2022- ASUDTAB meeting recommends that the omission of Rule 170 is not required
Apr 10, 2023- Association of Manufacturers of Ayurvedic Medicines (AMAM), one of the petitioners in the high court, gives a representation seeking repeal of Rule 170
May 1, 2023- High court dismisses all the petitions after central government tells high court that the matter will be placed before ASUDTAB for reconsideration
May 25, 2023- ASUDTAB discusses representation of AMAM and recommends omission of Rule 170
According to the minutes of the last meeting of the Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) held on May 25, the board has recommended the omission of Rule 170, which was inserted into the Drugs and Cosmetics Rules, 1945 in December 2018. Rule 170 was meant to prohibit advertisement of Ayurvedic, Siddha and Unani drugs without the ad being cleared by the licensing authority of the state where the manufacturer of the medicine is located or where the corporate office is located, in case the manufacturing is happening in more than one state.
Rule 170 had been brought in through an amendment to the rules after consultations with ASUDTAB in response to an increasing number of misleading advertisements of Ayush products. Moreover, in a report sumitted in March 2018, the parliamentary standing committee on health pulled up the ayush ministry and the health ministry for not bringing in a law to tackle the rising menace of misleading Ayush ads. In 2018, the Ayush minister revealed that the ministry had come across 804 instances of misleading advertisements or claims between April 2015 and January 2018. Pharmacovigilance centres of Ayush reported 1,127 cases of misleading advertisements from August 2018 to March 2019. However, in less than a month after the new Rule 170 was gazetted, several manufacturers went to court against the rule and in January 2019 the Delhi high court stayed its operation.
The minutes of the May meeting of ASUDTAB noted that the Association of Manufacturers of Ayurvedic Medicines had given a representation in April 2023 seeking the repeal of Rule 170. Dr CK Katyar, an industry representative, informed the board that provisions for prohibition of misleading advertisements were covered under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Consumer Protection Act. Dr Asad Mueed, yet another industry representative, also argued that there was no requirement of Rule 170 as proper implementation of Drugs and Magic Remedies (OA) Act 1954 was sufficient and that restriction on awareness spreading initiatives of the industry will be against the government’s commitment for propagating Ayush systems.
“This is a clear case of misleading the board. Drugs and Magic Remedies Act or the Consumer Protection Act will apply only after a misleading ad has appeared. Hardly any action gets taken when such complaints are filed and the cases drag on for years, by which time the intent of publishing such an ad will be met. Rule 170 was meant to be preventive. It would have prevented misleading ads from being published as these ads would first have to be cleared by the concerned state licensing authority. It is unfortunate that the government is buying the industry argument instead of working to protect public interest,” argued Dr KV Babu, an ophthalmologist and RTI activist who has filed several complaints against misleading Ayush ads. This will open the floodgates to misleading Ayush advertisements to the detriment of people’s health, he added.
On May 1, 2023 the government submitted in court that the matter would “be placed before ASUDTAB for reconsideration”. It failed to mention that the matter had already been taken up by ASUDTAB in its meeting in March 15, 2021 after recommendation by an expert committee of the Ayush ministry and that the board in its next meeting in June 2022 had recommended that there was no requirement to omit Rule 170.
Timeline of the efforts to combat misleading Ayush ads
Jan 20, 2017- Ayush ministry signs MoU with Advertising Standards Council of India (ASCI) to monitor misleading AYUSH-related advertisements in print and TV media. In one year following the MoU, ASCI reported 732 instances of such misleading ads
Mar 13, 2018- Parliamentary Standing Committee on health in its report expresses concern about misleading ads for Ayush products and pushes for a new law to prohibit them
Dec 21, 2018- Central Government gazettes the eleventh amendment of the Drug and Cosmetic Rule, 2018, by inserting Rule 170, which stipulated that all Ayush ads need to be cleared by state licensing authority. The new rule is framed in consultation with the technical board, ASUDTAB
Jan 15, 2019- Many Ayush manufacturers go to court. Delhi High court stays operation of Rule 170
Mar 15, 2021- Decision of omitting Rule 170 is taken by ASUDTAB after recommendation by an expert committee of the Ayush ministry
Jun 27, 2022- ASUDTAB meeting recommends that the omission of Rule 170 is not required
Apr 10, 2023- Association of Manufacturers of Ayurvedic Medicines (AMAM), one of the petitioners in the high court, gives a representation seeking repeal of Rule 170
May 1, 2023- High court dismisses all the petitions after central government tells high court that the matter will be placed before ASUDTAB for reconsideration
May 25, 2023- ASUDTAB discusses representation of AMAM and recommends omission of Rule 170