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From the Drug Controller General of India in 2007 (the sources seem to be off by a year, or maybe it's just bureaucracy delays) [1]:

> AGENDA ITEM NO.1

> CREATION OF A NEW SCHEDULE-H(1) AND CORRESPONDING CHANGES IN THE RULES UNDER THE DRUGS AND COSMETICS RULES FOR SPECIAL PRODUCTS WHICH ARE REOUIRED TO BE SOLD UNDER SPECIFIED CONDITIONS i.e. DICLOFENAC AND SPECIFYING CONDITIONS FOR SALE OF SUCH PRODUCTS.

> DCG(I) explained that at present the sale of drugs is regulated under Schedule-H (prescription drugs), and under Schedule-X {psychotropic or habit forming drugs). A need is, however, being felt that a separate Schedule is required to monitor, control and evaluate sales of certain specific drugs where it is not desirable to allow indiscriminate and unregulated access. Such drugs- would be regulated through a new Schedule i.e. Schedule-H(l). The specific sale conditions for the drug will be notified by the Ministry of Healthand FW through notification.

> The committee after deliberations agreed to the creation of a new Schedule-H 1 under the Drugs and Cosmetics Rules which would be strictly monitored by the State drug inspectors with a specific reference to Diclofenac preparations in respect of their veterinary use. The DCC also agreed to the prohibition of Diclofenac preparations for veterinary use. It further recommended that Diclofenac formulations meant for human use will print on their labels “Not for Veterinary Use”

[1] https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/U...



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