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Maharashtra FDA to urge Centre to bring amendments in D&C Act for better compliance
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Shardul Nautiyal, Mumbai
October 13 , 2018
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Maharashtra Food and Drug Administration (FDA) is planning to send a proposal to the central government to bring suitable amendments in drugs and cosmetics act to facilitate stringent action on drug retailers, wholesalers and manufacturers for non-compliance.
As of today, the state regulator can at the most suspend licenses for violations like absence of pharmacist among others but the offenders manage to get a stay from the appellate authority thus diluting the action taken.
“Drugs and Cosmetics (D&C) Act is a Central Act and approval to amend the provisions of the same is required from the Central government. An approval from the state cabinet has come recently and this will further be sent to the Centre for final approval to help make suitable amendments in drugs and cosmetics rules for better compliance at the state level,” said a senior FDA official.
As per official records, there are over 8,000 cases pending before the appellate authorities filed by drug retailers and manufacturers challenging state FDA action. Violations most of the time are related to not displaying license in the shop, not informing the licensing authority about the change in Pharmacists name and address and not disposing of drugs after expiry date.
There are over 76,800 chemist shops and 4,400 manufacturers in Maharashtra.
The state regulator has also written to the state government to bring in amendments 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 so that appropriate action can be taken against unregistered people selling spurious drugs in a clandestine manner without a license.
Under the current provisions of IPC, the state drug regulator cannot conduct a thorough investigation as there is a weak provision of imprisonment of only 6 months with or without 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.
Such amendments have been implemented in the states of West Bengal and Uttar Pradesh in the interest of patient safety.
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