To reduce and rationalize compliance burden for improving cost and ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) will soon remove 8 redundant compliances related to Drugs and Cosmetics (D&C) Rules-1945, Medical Devices Rules (MDR)-2017 and New Drugs and Clinical Trials (NDCT) Rules, 2019.
This is based on the data shared by the Department for Promotion of Industry and Internal Trade (DPIIT) under the Union Ministry of Commerce and Industry which it has sourced from Team Lease, a Third Party appointed for the same towards enhancing foreign investments in the country in a strategic manner.
Team Lease had identified 1,132 compliances related to D&C Rules – 1945, MD Rules- 2017 and NDCT – Rules, 2019 as burdensome, which are categorized as Rules or regulations based 3 compliances, Rule based and reviewable 399 compliances and Procedural Guidelines based 730 compliances.
Before the review process, CDSCO has convened several consultations with drugs manufacturers associations, chemists and druggists associations and consumer associations on the matter to seek their views and recommendations.
Drugs Technical Advisory Board (DTAB) has also been apprised about the exercise on rationalizing, simplifying and minimizing regulatory compliance burden on businesses in order to improve cost and ease of doing business in the India in a strategic manner with active support from the union ministry of commerce and industry which has been tasked as the Nodal Ministry for this exercise.
DPIIT has urged the Union health ministry to prepare a plan of action for reducing and rationalizing the overall compliance burden by examining Acts and compliances which are outdated in order to remove redundant laws and compliances, to do business process reengineering to reduce, rationalize, simplify the multitude of Acts, Rules, Administrative orders and to digitize all processes so as to do away with all physical submission of papers.
DPIIT has urged the union health ministry to also identify their respective areas of compliance and focus on executing the identified points to reduce compliance burden within the timeline of August 15, 2021 in case of compliances related to the D&C Act.
It has also urged to do business process reengineering to reduce, rationalize and simplify the multitude of Acts, Rules and Administrative orders.
The same issues were also deliberated in the 59th Drugs Consultative Committee (DCC) meeting held on March 02, 2021 and the DCC agreed to the proposed recommendations.
The DTAB in its 86th meeting held on April 13, 3021 also deliberated the matter and agreed to the recommendations of the 59th DCC and recommended to reduce above compliances burden by amending Rules under the D&C Act 1940.
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