Days after the Drug General Controller of India (DGCI) issued show cause notice to e-pharmacies over purported violations of the provisions of the Drugs and Cosmetics Act, CDSCO, state drugs controller and government regulators have decided hold a meeting in the last week of February in Hyderabad to formulate regulations to govern online pharmacies better. Moreover, the Food and Drug Administration has also launched a special drive to inspect stocking sites and keep a tab on records of prescriptions at local units of online pharmacies. Meanwhile, the All India Organisation of Chemists and Druggists had also planned to launch a nationwide month-long agitation from February 15 over the illegal practices by online pharmacies.
A senior official from the FDA Maharashtra said there are continuous vigilance checks on online pharmacies considering they are not following the provisions of the Drugs and Cosmetics Act. Moreover, they have conducted the drives jointly with the team from the Central FDA to conduct an inspection of stock, storage facilities, sales records and prescriptions.
“We had learnt that there are no proper prescriptions while supplying schedule H and X drugs, nor can they stamp the copies of the prescription, as contemplated under the Act. Besides, as per the Act, only a qualified pharmacist can hand over the drugs to the patient or their families which does not happen when selling drugs online. However one prescription is easily used multiple times which is a matter of concern following which there is an urgent need to ensure that one prescription can only be used once even at e-pharmacy claims that access to habit-forming drugs becomes much easier due to these websites,” he said.
On February 8, DGCI issued a show cause notice stating they had received various representations from time to time raising concerns regarding the sale of drugs through online, internet or other electronic platforms including various mobile applications, in contravention to the provisions of the Drugs and Cosmetics Act, 1940 & Rules there under.
“Such sale includes drugs specified in Schedule H, HI and X which are only allowed to be sold by retail under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist. In this regard, it may be mentioned that import, manufacture for sale or use, or sale, or stock or exhibit or offer for sale or distribution of any drug are regulated under the provisions of the Drugs and Cosmetics Act, 1940 & Drugs Rules 1945 made there under,” read show-cause notice.
Meanwhile, Abhay Pande, president of All Food and Drug Licence Holders’ Foundation said there is big nexus due to which no activities are being taken against the online pharmacies which started in 2016. DGCI being the sole body to formulate and regulate the law still e-pharmacies being run under their nose who are violating the Drugs and Cosmetics Acts 1940.
“DGCI has turned a blind eye and should feel ashamed for not taking action against online pharmacies. There are several high courts have intervened in the matter time and again. In the last seven years, there has been no action from the authorities. Now also DGCI is seeking answers from them of what wrong their doing by selling medicines online,” he said.
The notice from the drug regulator states that the sale, stock or exhibit or offer for sale or distribution of drugs online, internet or on other electronic platforms without a license has a potential impact on the quality of drugs and pose risk to public health due to potential misuse of drugs through self-medication, indiscriminate use of the drugs.
"In view of the above, you are hereby asked to show cause within 02 days from the date of issue of this notice, why action shall not be taken against you for the sale, or stock or exhibit or offer for sale or distribution of drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder," the notice of DCGI to e-pharmacies said.
