The guidelines for storage of drugs are not being properly followed by manufacturers, distributors and retailers across the country leading to 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 aCommittee on Subordinate Legislation over a representation on the issue, saidthat starting from drug manufacturing companies to distributors and chemists,nobody follows guidelines on drugs storage, properly leading to degradation ofeffectiveness of medicines and in many cases early expiry.
The Drugs and Cosmetics Act and the rules specify in detailparameters on premises, surroundings, sanitation, storage of raw materials,documentation and quality control systems among others that a manufacturer isrequired to comply with under the conditions of licence, a senior officialsaid.
“The rules prescribe conditions to be satisfied beforegrant of licence for sale of drugs. These include adequate space, properstorage facilities for preserving the properties of drug.
“Storage of any drug under the recommended condition isimportant to ensure that they remain stable throughout their shelf life. If notstored properly, the drug may lose its efficacy and many lead totoxicity,” the official said.
Rule 65 under the Drugs and Cosmetics Act prescribes variousconditions required to be followed by the licensee.
These include requirements of registered pharmacists forretail sale, prescription of registered medical practitioners for sale ofprescription drugs by retail, maintaining records among others.
“Concerns have however been raised from time to timeregarding bad storage conditions by the manufacturers, wholesalers andretailers. The Masheklar Committee recommended one inspector for 200 salesoutlets and one inspector for 50 manufacturing units.
“There are more than eight lakh sales outlets in thecountry and more than 1,000 manufacturing units. Accordingly, 4,200 druginspectors are needed,” the official said.
As on April 2018, the total sanctioned strength of druginspectors in the states and Union Territories is about 1,600, out of whichabout 1,200 drug inspectors are available. In CDSCO, as on January 2019, 224drug inspectors are in position.
The issue has been deliberated multiple times in themeetings of Drugs Consultative Committee (DCC), a statutory body under the Actand drug controllers of all states and Union Territories are its members.
The DCC after detailed deliberation has finalized GoodDistribution Practices guidelines to be followed by the manufacturerswholesalers and retailers to ensure that the drugs are stored under properstorage conditions throughout the supply chain.
The ‘good distributions practices’ contain guidelinesregarding premises, warehousing and storage, temperature, environment andstorage control transportation, shipment containers and labelling, dispatch andreceipt, documentation complaints, recalls and returns, spurious pharmaceuticalproducts, importation, contract activities and self-inspection, the officialsaid,.These guidelines are applicable to all personsand outlets involved in any aspect of the storage and distribution ofpharmaceutical products.