The Drugs Technical Advisory Board (DTAB), which recommends on policy decisions related to technical matters on the Drugs and Cosmetics Act and relevant rules, has given its green signal to amend the Drugs and Cosmetics Rules, 1945 to incorporate guidelines on Good Distribution Practices (GDP) for pharmaceutical products.
The move will give legal sanctity to the guidelines approved by the Drugs Consultative Committee (DCC) in its meeting last year, with certain minor corrections.
The Board, in a meeting on February 16, considered the recommendations of the DCC meeting held on June 17, 2025.
"DTAB after deliberation suggested certain minor corrections in the guidance document and agreed to appropriately amend the Drugs Rules, 1945 for imparting legal sanctity to the suggested guidelines for all the firms holding license to manufacture for sale, sell, stock, exhibit or offer for sale or for distribution of drugs," said the minutes of the latest meeting.
The DCC in its 66th meeting in June, last year, agreed with the proposal to amend the Drugs Rules, 1945, to include guidelines on Good Distribution Practices for pharmaceutical products as a schedule, after consultation with the stakeholders.
The proposal was approved by the Committee in an earlier meeting and came up for further discussion in the 66th meeting, since the proposed guidance document was put for consultation with stakeholders.
The draft guideline for inclusion as a schedule under the Drug Rules has been prepared in line with revised World Health Organisation (WHO) Technical Report Series (TRS) guidelines and applicable rules. When it came up for discussion in a previous DCC meeting, in June, 2024, the committee opined that the proposed guidelines should be deliberated in consultation with stakeholders before taking further action.
Following this, a stakeholder’s consultation was conducted on the GDP guidelines and the comments received were deliberated by the DCC.
"DCC was also apprised about the concerns raised by the stakeholders and DCC after detailed deliberation agreed with the proposal to appropriately amend the Drugs Rules, 1945," said the Committee in its minutes to the latest meeting.
It may be noted that the Parliamentary Panel on Chemicals and Fertilisers has earlier this year recommended the Department of Pharmaceuticals (DoP) to make GDP legally enforceable to act as deterrent against the prevalence of spurious and substandard drugs in the country
The DCC, earlier while discussing the inclusion of the separate schedule, in January, 2024, observed that due to the non mandatory nature of guidelines, the maintenance of storage condition of drugs during transit till wholesale and retail level is not being ensured by the manufacturers. The guidelines were being revised during the time in line with the revised WHO guidelines in 2020.
It agreed that the revised GDP guidelines should be circulated to the States and Union Territories before finalising and once it is finalised, it should be made part of the Rules to provide legal backing. It also recommended inclusion of the GDP guidelines in the Drugs Rules, 1945.
The matter was once again taken up for deliberation in a DCC meeting in June, 2024, during which the Committee observed that the draft guideline should be included as a schedule under the Drug Rules in line with revised WHO TRS guidelines and applicable rules.
"After detailed deliberation, the committee opined that the proposed guidance document may be deliberated in consultation with stakeholders before taking further action," it added during the time.
The implementation of Good Distribution/Storage Practices was also deliberated in the 54th DCC meeting held on July 30, 2018 and it was suggested to take necessary provisions to impart legal sanctity to the suggested guidelines as Schedule to the Drugs & Cosmetics Act, 1945. Following this, the CDSCO had drafted guidelines on GDP in the year 2018 and it was published for stakeholders’ comments.
The industry has been seeking the government to look into the issues related to transportation and storage of medicines, since these factors can affect the quality of the medicine, which ultimately becomes the responsibility of the manufacturer. |