With the reports of steady increase in the sale of spurious drugs by unregistered drug dealers without any license, Maharashtra Food and Drug Administration(FDA) has proposed to the state government to make 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 Drugs and Cosmetics (D&C Act), 1940 so that appropriate action can be taken against unregistered people selling spurious drugs in a clandestine manner without any license.
Current provisions of IPC, not allowed the state drug regulator to 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. Selling of fake medicines is a big crime and imprisonment of only 6 months is not sufficient. D&C Act provisions for similar crimes are like life imprisonment and fine of not less than Rs.10 lakhs or three times of the spurious product confiscated.
“Besides this, the amendments are very much required as unregistered people cannot be brought to book as they do not fall under the ambit of drug regulations as provisioned under D&C Act. This has led us to rely on police investigations without actually investigating the matter in the context of drugs which pose serious health concerns for the public at large,” says Maharashtra FDA Joint Commissioner Amrut Nikhade.
Such amendments have been implemented in the states of West Bengal and Uttar Pradesh in the interest of patient safety.
“In the absence of stricter provisions of IPC, despite having stricter provisions under D&C Act, FDA cannot conduct investigations because D&C At only empowers search and seizure of products and arrests can only be made through a proper investigative procedure which warrants times and evidence. Therefore, the stricter IPC provisions are urgently required so that grievous hurt or damage to the patient or consumer can be averted in a timely manner,” says a senior FDA official.
In most of the cases, the offender gets a bail and continues to do the nefarious activity of selling spurious drugs to gullible customers. The proposal was discussed with key officials of the Maharashtra FDA and state home ministry recently. The proposal has been submitted to the state government subsequent to which the proposal will go to the Central Government for facilitating the necessary amendments.
This will also help FDA to follow the case after FIR has been lodged so that apt action would be taken once the charge sheet has been filed.
As per the current provisions of the D&C Act, any person who manufactures for sale or for distribution or sells or stocks or exhibits or offers for sale or distributes any drug deemed to be adulterated under section 17 A or spurious under section 17 B and which when used by any person for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the IPC (45 of 1860) solely on account of such drug being adulterated or spurious or not-of -standard quality, as the case may be, shall be punishable with imprisonment for a term which shall be not less than 10 years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than Rs.10 lakhs or three times the value of the product confiscated, whichever is more.
Maharashtra FDA detected drug dealers in Aurangabad who were selling ayurvedic medicines containing scheduled allopathic drugs like sildenafil citrate and anesthetic medicine – lignocaine hydrochloride.