To ensure compliance to the conditions of licence and Drug Price Control Order (DPCO-2013), Maharashtra Food and Drug Administration (FDA) has filed FIRs against four people at Dongri Police Station in South Mumbai for illegally selling and stocking medicines. According to an FDA official, these persons have been arrested and action will be initiated against them for violating the conditions of licence under Section 18 of the Drugs and Cosmetics Act, 1940.
The arrested persons were selling prescription drugs at exhorbitant prices in contravention to DPCO- 2013, Section 7 of Essential Commodities Act (EC Act) and Drugs and Cosmetics Act. This is amongst the first few such cases detected by the state regulator since it intensified its drive two months ago against people stocking and selling drugs illegally.
The state as of today has 18,000 wholesalers including those who export and import. Out of which, there are around 4,000 stockists who supply to the retail trade. FDA had intensified the crackdown on the errant wholesalers since the past two months considering the fact that until last year unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant.
FDA started the drive to inspect licences of 18,000 drug wholesalers in the state from July, 2014 onwards to detect malpractices related to violations of conditions of licence. Drug wholesalers have however alleged that FDA officials have been seeking irrational data like bank statements, annual turnover and profit margins which is not in accordance to officials' enquiry rules. FDA officials however explain that D&C Act empowers the drug inspector to examine any record, register, document or any other material object found and seize the same if he has reason to believe that it may furnish evidence of the commission of an offence punishable under the D&C Act or the Rules made thereunder.
The duties of a drug inspector for inspecting the premises of a licenced drug wholesaler are prescribed under Rule 51 (1) of the D&C Rules, 1945. It empowers the drug inspector to inspect, not less than once a year, all establishments licenced for the sale of drugs within the area assigned to him, to satisfy himself that the conditions of the licences are being followed and to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act.
A senior FDA official further explains that a drug inspector is empowered to inspect the wholesaler's premises also under Section 22 of the Drugs and Cosmetics Act and can ask for details like bank statements, annual turnover and profit margins for the sake of verification and clarity.