[ad_1]
The Drug Controller General of India (DCGI) put a spoke in the wheel of a move to withdraw a rule that regulated advertisement of ayush drugs products by suggesting that it be withdrawn only after amendments to strengthen the Drugs and Magic Remedies Act are passed. However, file notings given as part of an RTI response from the health ministry show that the proposed amendments have been in limbo since November last year.
Rule 170, gazetted in December 2018, mandated that all advertisements for ayush drugs would have to be previewed and cleared by the regulator before being publicised. However, several ayush drug makers challenged this rule.
The Ayurvedic Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) took up the issue of omission of Rule 170. However, in its meeting in June 2022, according to the minutes of the meeting obtained through RTI, then DCGI, Dr VG Somani suggested that “it is not ethical to omit the existing Rule in anticipation of its inclusion in the proposed amendment of DMR Act”. “Once the concerned provisions were adopted and notified in the proposed Act we may go ahead with the omission of this Rule. Since there were no comments received from the members and hence the minutes were confirmed unanimously except Omission of Rule 170,” stated the minutes.
“The omission of Rule 170 is subject to the enactment of the amendment to the Drugs and Magic Remedies (Objectionable Advertisements) or DMR (OA) Act 1954 and it is obvious from the ministry’s response that there has been no progress on the amendment bill since last year,” argued Dr KV Babu, ophthalmologist and RTI activist, in his letter to the health ministry.
However, according to ayush ministry’s communication to Dr Babu in October this year, “the decision for omission of Rule 170 was a conscious decision taken by the ASUDTAB in its earlier meeting dated 15-03-2021 considering policy of the government to promote ease of doing business”. Ayush ministry stated that in the last meeting of ASUDTAB held on May 25, 2023, the matter related to Rule 170 of Drugs and Cosmetics Rules, 1945 was discussed and it had been recommended by the board “to proceed with final notification for omission of Rules 170 and its related provisions mentioned in D&C Rules, 1945”.
“It is clear that, the recommendation of ASUDTAB in its meeting held on May 25 to omit Rule 170 is contradictory to the earlier approved minutes of ASUDTAB on June 27 last year when the DCGI pointed out that it ought to be withdrawn only after amendments to DMR(OA) are enacted,” said Dr Babu. Interestingly, though the minutes of the June 2022 and May 2023 meetings of ASUDTAB have been made available, ayush ministry had not shared the minutes of the March 2021 meeting in which the ministry claims “a conscious decision” to omit Rule 170 was taken.
Though ASUDTAB is said to have approved the omission of Rule 170, the omission has not yet been gazetted.
Rule 170, gazetted in December 2018, mandated that all advertisements for ayush drugs would have to be previewed and cleared by the regulator before being publicised. However, several ayush drug makers challenged this rule.
The Ayurvedic Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) took up the issue of omission of Rule 170. However, in its meeting in June 2022, according to the minutes of the meeting obtained through RTI, then DCGI, Dr VG Somani suggested that “it is not ethical to omit the existing Rule in anticipation of its inclusion in the proposed amendment of DMR Act”. “Once the concerned provisions were adopted and notified in the proposed Act we may go ahead with the omission of this Rule. Since there were no comments received from the members and hence the minutes were confirmed unanimously except Omission of Rule 170,” stated the minutes.
“The omission of Rule 170 is subject to the enactment of the amendment to the Drugs and Magic Remedies (Objectionable Advertisements) or DMR (OA) Act 1954 and it is obvious from the ministry’s response that there has been no progress on the amendment bill since last year,” argued Dr KV Babu, ophthalmologist and RTI activist, in his letter to the health ministry.
However, according to ayush ministry’s communication to Dr Babu in October this year, “the decision for omission of Rule 170 was a conscious decision taken by the ASUDTAB in its earlier meeting dated 15-03-2021 considering policy of the government to promote ease of doing business”. Ayush ministry stated that in the last meeting of ASUDTAB held on May 25, 2023, the matter related to Rule 170 of Drugs and Cosmetics Rules, 1945 was discussed and it had been recommended by the board “to proceed with final notification for omission of Rules 170 and its related provisions mentioned in D&C Rules, 1945”.
“It is clear that, the recommendation of ASUDTAB in its meeting held on May 25 to omit Rule 170 is contradictory to the earlier approved minutes of ASUDTAB on June 27 last year when the DCGI pointed out that it ought to be withdrawn only after amendments to DMR(OA) are enacted,” said Dr Babu. Interestingly, though the minutes of the June 2022 and May 2023 meetings of ASUDTAB have been made available, ayush ministry had not shared the minutes of the March 2021 meeting in which the ministry claims “a conscious decision” to omit Rule 170 was taken.
Though ASUDTAB is said to have approved the omission of Rule 170, the omission has not yet been gazetted.
[ad_2]
Source link
More Stories
Congress replaces Kamal Nath, names an OBC as Madhya Pradesh chief | India News
Fire breaks out in ITBP camp in Srinagar; none hurt | India News
Parliament Security: Co-villagers give clean chit to Lalit Jha, parents to move court | India News