This article details the guidelines by the State Drug Control Organizations for uniform implementation of the provision of the Drugs and Cosmetics Act. In implementing the new CDSCO license provisions, the State Drug and Cosmetic Regulatory Authorities must ensure that the law is implemented comprehensively.
CDSCO License: Standard Operating Procedure
To effectively implement the instrument of law, every CDCSO license applicant must follow the Standard Operative Procedures set for each State. They must examine and process various violations of the provision of the CDSCO Act.
CDSCO License: Checks and Balance Mechanisms
Also, the State Drug Control Organizations must implement an internal mechanism of checks and balances. Such a mechanism ensures the non-harassment of law-abiding manufacturers and sellers of drugs. This also ensures that the said manufacturers are not put in a disadvantageous position.
CDSCO License: Actions in case of Act Violations
Every CDSCO license applicant must distance themselves from such kinds of CDSCO Act violations. The Authority must deal with a heavy hand if criminal intent or negligence violations lead to serious defects. But for violations involving minor variations in quality by cosmetic manufacturers, the Authority must resolve them through administrative measures.
Investigation against an unlicensed Cosmetic Manufacturer
If the Authority detects any spurious or imitation drug products by unlicensed manufacturers or cosmetic sellers, then it will initiate an investigation on top priority as per the provisions of the Cosmetic Act. The actions will be initiated under which the offenses are otherwise considered cognizable and non-bailable.
If necessary, the Authority can obtain help from the enforcement agencies like the police to bust the rackets and book the culprits in time. The Regulating Authority must then expedite the investigations and launch the prosecutions at the earliest. The quick and timely investigations by the Authority will have deterrent effect on the unscrupulous persons involved in the illegal trade of spurious drugs.
Also Read: Trademark Infringement
Investigation against a licensed Cosmetic Manufacturer
Suppose a licensed manufacturer uses its licensed premises to manufacture spurious drugs. Also, his criminal intent is apparent. Then the Regulating Authority will file a case against the licensed Manufacturer to pursue with equal vigour as in the case of an unlicensed manufacturer. The investigations must encompass other activities the Manufacturer carries out on his licensed premises.
Investigation against Manufacturer of sub-standard products
Let us consider the case of a range of cosmetics manufactured by a licensed manufacturer. Such entities with a valid manufacturing license have the product of grossly sub-standard quality. In that case, the Authority will initiate an investigation at the Manufacturer’s end. Suppose criminal intent or gross negligence is found on the Manufacturer’s part, and the administrative resolutions are insufficient to meet justice. In that case, the Authority can re-course to prosecution.
Investigation against Manufacturer for minor defects
If the quality check report of cosmetics yields negative because of minor defects arising out of variations and if they deviate from the prescribed standards and contraventions of provisions of the CDSCO Act, then the Authority can initiate administrative measures. These measures include suspension or cancellation of CDSCO license or compounding of offenses. They must launch the prosecution when they feel that the above measures will not meet the ends of justice.
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