The new rules will be drafted in four months
New Delhi: The government wants to examine rules and regulations to make e-pharmacies—online chemists—a “safer and viable option” for consumers, drugs controller general G.N. Singh said.
The new rules will be drafted in four months.
Several guidelines and issues were discussed between the Drugs Controller General of India (DCGI) and various stakeholders on Wednesday at a meeting organised by industry lobby the Federation of Indian Chambers of Commerce and Industry.
“New rules need to be drafted and that shall take anywhere between three-four months before being presented to the government for discussion but the outlook is positive for e-pharmacies,” the DCGI said.
“The government and regulatory authorities welcome the inclusion of technology but we must keep in mind the interests of chemists and the safety of patients,” Singh said.
As of now, there is no provision in the law to properly govern online retailers for medicines, he added.
Wednesday’s discussions highlight an urgent issue.
Selling prescription drugs on the Internet is banned in India. But in May, Maharashtra’s Food and Drugs Administration (FDA) filed an FIR against e-commerce website Snapdeal.com’s CEO Kunal Bahl and directors of the company in a case related to online sales of prescription drugs.
The website had on sale about 45 drugs with claims that the FDA alleged contravened provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
Snapdeal’s defence was that it played the role of an intermediary and had tried its best to educate retailers on how to engage in fair and safe sales and the consequences of selling inappropriate products—Schedule H drugs in this case.
The Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 have guidelines on the sale of scheduled drugs, which can be sold only on prescription.
“The Drugs and Cosmetics Act does not cover all loopholes and we also need a clearer definition of OTC (over-the-counter) drugs to make e-commerce of drugs a safer and viable option,” Singh said on Wednesday.
Currently there are three models of online pharmacy that exist in India—organised, unorganised and illegal. In the organized sector, technology is used to either connect local licensed pharmacists to the end user or an off-line pharmacist takes orders over the internet. Prescriptions are checked in the organised sector while the unorganised sector does away with this requirement.
Increased convenience, availability and greater access to medicines some of the few benefits of online pharmacies but vetting pharmacists for licenses and storage was a concern voiced at the meeting.
Prashant Tandon, CEO of 1mg.com, an online pharmacy start-up, said, “There needs to be a marketplace model to ensure consumers are equipped with information and they have to upload prescriptions to ensure authenticity of the purchase.” He said security concerns over the misuse of such portals were valid and that they could be addressed by putting in place proper mechanisms for verification.
The national general secretary of Indian Medical Association (IMA) India, Dr. K K Aggarwal, voiced several concerns. “Doctors, patients and pharmacists have a relationship based on trust. If a website were to display cheaper variations to the medicine I prescribe, without offering an explanation, this relationship suffers. Quality comes at a cost,” he said.
He added that verification of doctors could be a problem as medical licenses could easily be forged.
SOURCE: Live Mint| 19th June 2015
