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    • Improper storage kills...

    Improper storage kills shelf life of drugs; Health Ministry raises concern

    Meghna A SinghaniaWritten by Meghna A Singhania Published On 2019-05-15T09:31:49+05:30  |  Updated On 15 May 2019 9:31 AM IST
    Improper storage kills shelf life of drugs; Health Ministry raises concern

    As on April 2018, the total sanctioned strength of drug inspectors in the states and Union Territories is about 1,600, out of which about 1,200 drug inspectors are available. In CDSCO, as on January 2019, 224 drug inspectors are in position.


    New Delhi: The guidelines for storage of drugs are not being properly followed by manufacturers, distributors and retailers across the country leading to a deterioration of the quality of medicines available in the market, sources in the Union health ministry has said.


    According to the sources, the ministry in its reply to a Committee on Subordinate Legislation over-representation on the issue said that starting from drug manufacturing companies to distributors and chemists, nobody follows guidelines on drugs storage, properly leading to degradation of the effectiveness of medicines and in many cases early expiry.


    Read Also: Trump says he will allow US states to buy cheaper medicines from abroad


    The Drugs and Cosmetics Act and the rules specify in detail parameters on premises, surroundings, sanitation, storage of raw materials, documentation and quality control systems among others that a manufacturer is required to comply with under the conditions of the licence, a senior official said.


    "The rules prescribe conditions to be satisfied before granting of a licence for sale of drugs. These include adequate space, proper storage facilities for preserving the properties of the drug.


    Read Also: Medlife acquires medicine delivery startup Myra Medicines


    "Storage of any drug under the recommended condition is important to ensure that they remain stable throughout their shelf life. If not stored properly, the drug may lose its efficacy and many leads to toxicity," the official said.


    Rule 65 under the Drugs and Cosmetics Act prescribes various conditions required to be followed by the licensee.


    These include requirements of registered pharmacists for retail sale, prescription of registered medical practitioners for sale of prescription drugs by retail, maintaining records among others.


    "Concerns have however been raised from time to time regarding bad storage conditions by the manufacturers, wholesalers and retailers. The Masheklar Committee recommended one inspector for 200 sales outlets and one inspector for 50 manufacturing units.


    "There are more than eight lakh sales outlets in the country and more than 1,000 manufacturing units. Accordingly, 4,200 drug inspectors are needed," the official said.


    As on April 2018, the total sanctioned strength of drug inspectors in the states and Union Territories is about 1,600, out of which about 1,200 drug inspectors are available. In CDSCO, as on January 2019, 224 drug inspectors are in position.


    The issue has been deliberated multiple times in the meetings of Drugs Consultative Committee (DCC), a statutory body under the Act and drug controllers of all states and Union Territories are its members.


    The DCC after detailed deliberation has finalized Good Distribution Practices guidelines to be followed by the manufacturer's wholesalers and retailers to ensure that the drugs are stored under proper storage conditions throughout the supply chain.


    Read Also: Now State Drug Controllers to have authority to issue STOP SALE order of Medicines: CDSCO to amend to rule


    The 'good distributions practices' contain guidelines regarding premises, warehousing and storage, temperature, environment and storage control transportation, shipment containers and labelling, dispatch and receipt, documentation complaints, recalls and returns, spurious pharmaceutical products, importation, contract activities and self-inspection, the official said,


    These guidelines are applicable to all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products.

    CDSCOdeteriorationdrug storagedrugsDrugs and Cosmetics ActDrugs Consultative CommitteeGood Distribution Practices guidelinesHealth Ministrymedicinequality of medicinesRule 65 Drugs Actstorage guidelinesToxicityUnion Health Ministry
    Source : PTI

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    Meghna A Singhania
    Meghna A Singhania

      Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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