Drugs and Cosmetics Act need new amendments as per the Maharashtra Food and Drug Administration (FDA). Maha FDA planned to write a proposal to the central government to make required changes in the drugs and cosmetics act. These changes are highly desired to facilitate stringent action on drug retailers, wholesalers, and manufacturers for non-compliance.
Senior FDA official said that Drugs and Cosmetics (D&C) Act is a Central Act. To change any of its provisions, required approval from the Central government as well. The state cabinet recently approved the request of the amendment and this will further sent to the Centre government for final approval. Once the central government approved the proposal then this act get amended. This will make suitable amendments in drugs and cosmetics rules for better compliance at the state level.
As per the current act, the state regulator can’t take strict action for breaching like the absence of pharmacist on the pharmacy shop but the culprits easily manage to get a stay from the appellate authority thus diluting the action taken by the state regulator.
More than 8000 cases are still pending before the appellate authorities filed by drug retailers and manufacturers that challenging state FDA action. Common violations are the absence of displaying the valid license in the shop, not informing the licensing authority about the change in Pharmacists name and address and not disposing of drugs after the expiry date.
Only in Maharashtra, more than 76,800 chemist shops operating and 4,400 drug manufacturer units are running. To handle violations strictly,the state regulator has also written to the state government to bring in changes in the relevant sections of 274, 275 and 276 of Indian Penal Code (IPC) to make it on par with the Section 27 (a) and Section 27 (c) of the D&C Act, 1940. These changes help state regulator to take an appropriate action against unregistered people who are mostly involved in selling spurious drugs in a clandestine manner without a license.
With the current provisions of IPC, the state drug regulator don’t have authority to conduct a thorough investigation as there is a weak provision of imprisonment of only 6 months with or without a fine of up to Rs.10,000. This is much less as compared to the D&C Act which provisions for life imprisonment and fine of not less than Rs.10 lakh or three times of the spurious product confiscated.
To ensure the safety of the citizens, these amendments should also be implemented in the states of West Bengal and Uttar Pradesh in the interest of patient safety.