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In a bid to crack down on illegal commercial sale of drugs the CDSCO has written to all state and zonal drug inspectors to conduct surprise inspections across the six lakh chemist shops scattered around the country. These drugs are usually distributed as free samples by docs or used by government stores depots, the Armed Forces' medical stores and other government institutions.
The Drug Controller General of India (DCGI) has asked all controllers to check if the drugs are being kept under lock and key. The letter says, "no person dispensing a prescription containing substances specified on Schedule H or X may supply any other preparation whether containing the same substance or not." Drugs belonging to Schedule X can only be sold by around 480 select chemists and record of sales of this drug has to be maintained for a period of two years. Under Schedule H, drugs can be stocked by chemists but sold only against prescription of a registered medical practitioner.
It explains, "A retail chemist is a vital link in the distribution chain of drugs from where drugs reach to the consumers. The rule 65 prescribes in detail various requirements which have to be complied by the licencees. In order to ensure that the chemists comply with the requirements, drug inspectors may be directed to make surprise inspections of chemist shops in their respective jurisdictions to ensure that the conditions are complied with."
It also asks chemists and druggists associations in states to comply with the provisions of the Drugs and Cosmetics Act.
The letter says, "Supply of drugs specified in schedule X shall be maintained separately. Substances specified in schedule H or X shall not be sold by retail except on and in accordance with the prescription of a registered medical practitioner and in the case of substances specified in schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years."
The health ministry is also trying to implement a stricter pharma laws. Under these suggestions, it says free sample shall not be supplied to any unqualified person.
"Where samples of products are distributed by a medical representative, the sample must be handed directly to a person qualified to prescribe such product or to a person authorized to receive the sample on their behalf. Such samples are provided on an exceptional basis only and for the purpose of acquiring experience in dealing with such a product. Such sample packs shall be limited to prescribed dosages for three patients. Any supply of such samples must be in response to a signed and dated request from the recipient. Each sample shall be marked free medical sample - not for sale," the code said.
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