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DCC asks committee revisiting Rule 64 to place report for further discussion
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Gireesh Babu, New Delhi
September 30 , 2024
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The Drugs Consultative Committee (DCC), which advises the Centre and the States on the matters that requires uniform implementation of drug laws across the country, has asked the committee formed by the Central Drugs Standard Control Organisation (CDSCO) to revisit the Rule 64 of Drugs Rules, 1945, to place its report before the DCC for further discussion and consideration.
The DCC meeting held on June 19, 2024, agreed with the committee constituted by the CDSCO earlier this year, for revisiting the particular Rule under Part VI of the Drugs Rules, pertaining to sale of drugs other than homoeopathic medicines "with regards to the present scenario." The conditions of Rule 64 prescribe the conditions to be satisfied before a license in various forms related to sale of drugs is granted.
The Central drug regulator constituted a committee comprising Drugs Controller, Odisha, Drugs Controller, Madhya Pradesh, Drugs Controller, Punjab, Drugs Controller, Telangana and DDC (I), Enforcement cell, as Convener for the purpose on May 20, to revamp the drug selling practices in the country. The committee was instructed to submit its report in two months.
Agreeing to the constitution of the Committee, the DCC recommended "that the report of the committee should be placed before the DCC for further discussion and consideration". It may be noted that some of the stakeholders have requested that their views should also be taken into account by the committee, while revisiting the rule.
As reported earlier, the decision to form the Committee was in line with an earlier recommendation of the DCC regarding inclusion of Good Distribution Practices (GDP) into the Drugs Rules.
In a previous meeting, the DCC recommended that the revised GDP guidelines for pharmaceutical products should be made part of the Drugs Rules, 1945 to ensure proper implementation across the supply chain.
The CDSCO has released the draft guidelines on GDP in line with the World Health Organisation's (WHO) Technical Report Series (TRS) on Good Storage and Distribution Practices for pharma products to avoid the introduction of spurious, adulterated, misbranded and Not of Standard Quality (NSQ) products into the market.
The DCC discussed the proposal to make guidelines on GDP under separate Schedule to the Drugs Rules, 1945, observing 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.
“DCC agreed that revised Good Distribution Practices guidelines should be circulated to all States/Union Territories before finalising and once it is finalised, it should be made part of the Rules to provide legal backing…” said the Committee. Accordingly, DCC recommended for inclusion of the GDP guidelines in the Drugs Rules, 1945.
According to Drugs and Cosmetics Act, 1940 and Drugs Rules 1945, Rules 64 and 65 specify the conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute the drugs. It shall be the responsibility of all parties involved in the distribution of pharmaceutical products to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or their agent.
In order to maintain the quality of the pharmaceutical products, adequate control over the entire chain of distribution is required to be maintained.
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 draft guideline is now under further revision in line with the revised WHO guidelines, 2020.
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 an issue to the manufacturer.
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