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Maharashtra FDA acted swiftly against Snapdeal and filed FIR in connection with sale of prescription drugs. In an interview with Sanjay Jog, FDA Commissioner Harshdeep Kamble explains how they dealt with the matter.
What prompted FDA to take action against e commerce companies especially Snapdeal for sale of prescription drugs?
At the outset let me tell you that under the Drugs & Cosmetics Act, 1940, the on line sale of prescription drugs is not allowed. It is only the doctor who knows which medicine to be prescribed and what would be the dose required for patient.
It is only the authorized and licensed pharmacists who are allowed to give that medicines based on the doctor's prescription. There are very strict rules as there is human life involved and it is at stake.
In connection with the recent action against Snapdeal, FDA had received a complaint that some e commerce companies through their websites are selling on line the prescription drugs which has to be sold only on the prescription of doctor and by a licensed pharmacists.
We thoroughly investigated the matter. The complainant then came to FDA with regard to the sale of medicines such as Ascoril cough syrup and Vigora tablets.
The complainant, who had ordered on Snapdeal on line, received those medicines through couriers. Subsequently, FDA formed the special investigation team (IT) an simultaneously started scanning other e commerce websites. FDA found that certain other on line companies were also show casing those medicines on their websites.
As per the Drugs and Cosmetics Act, offer of a sale of medicine and even an exhibition are not allowed unless and until certain procedures are followed. Thereafter, FDA issued notices to Snapdeal, Flipkart, Amazon and two three others. Many replied saying that that they are delisting those medicines from their websites.
What prompted FDA to take action against e commerce companies especially Snapdeal for sale of prescription drugs?
At the outset let me tell you that under the Drugs & Cosmetics Act, 1940, the on line sale of prescription drugs is not allowed. It is only the doctor who knows which medicine to be prescribed and what would be the dose required for patient.
It is only the authorized and licensed pharmacists who are allowed to give that medicines based on the doctor's prescription. There are very strict rules as there is human life involved and it is at stake.
In connection with the recent action against Snapdeal, FDA had received a complaint that some e commerce companies through their websites are selling on line the prescription drugs which has to be sold only on the prescription of doctor and by a licensed pharmacists.
We thoroughly investigated the matter. The complainant then came to FDA with regard to the sale of medicines such as Ascoril cough syrup and Vigora tablets.
The complainant, who had ordered on Snapdeal on line, received those medicines through couriers. Subsequently, FDA formed the special investigation team (IT) an simultaneously started scanning other e commerce websites. FDA found that certain other on line companies were also show casing those medicines on their websites.
As per the Drugs and Cosmetics Act, offer of a sale of medicine and even an exhibition are not allowed unless and until certain procedures are followed. Thereafter, FDA issued notices to Snapdeal, Flipkart, Amazon and two three others. Many replied saying that that they are delisting those medicines from their websites.
FDA by then found out the modus operandi and tried to get some more material as evidence. Later, FDA ordered through its staff some medicines on line and they received them from Snapdeal and thereafter decided to proceed further and filed an FIR.
But e commerce companies argue that they are virtual market place. What is your comment?
As far as pharmacists are concerned, they are licensed and registered. FDA officials regularly visit, monitor, inspect their shops thereby there is some kind of quality check on them.
In case of e commerce companies, there are no checks and counterchecks. What FDA fears is that counterfeit and fake medicines can also be sold in this fashion because it is individual who is placing an order on line. This may adversely affect the patient. Argument of e commerce companies is that they are a virtual market place.
However, acting as doctor and pharmacists they are not allowed to do so. Another point is that selling clothes, apparels and other things is different from sale of medicines. There is no adverse effect on human health due to the sale of apparels and others but sale of medicines do have.
If some one takes overdose of the medicine and has its reaction who is responsible for this. If patient had gone through a doctor he or she can file complain against the said doctor or pharmacist.
But e commerce companies argue that they are virtual market place. What is your comment?
As far as pharmacists are concerned, they are licensed and registered. FDA officials regularly visit, monitor, inspect their shops thereby there is some kind of quality check on them.
In case of e commerce companies, there are no checks and counterchecks. What FDA fears is that counterfeit and fake medicines can also be sold in this fashion because it is individual who is placing an order on line. This may adversely affect the patient. Argument of e commerce companies is that they are a virtual market place.
However, acting as doctor and pharmacists they are not allowed to do so. Another point is that selling clothes, apparels and other things is different from sale of medicines. There is no adverse effect on human health due to the sale of apparels and others but sale of medicines do have.
If some one takes overdose of the medicine and has its reaction who is responsible for this. If patient had gone through a doctor he or she can file complain against the said doctor or pharmacist.
However, in case of e-commerce companies they are taking a stand that they are a market place nothing else. If there is a racket of counterfeit medicines who will be responsible for this?
These are very dangerous trends and therefore unless and until there are counter checks and balances such sale of prescribed medicines should not be practiced. Since the Act does not allow it, FDA had taken the action.
Maharashtra FDA had written to GoI and other states about on line sale of prescription drugs. What is their response?
Telangana state also acted similarly, issued notices to on line e commerce companies and asked them to stop sale of medicines on line. Similar action is being taken in one or two more states.
Do you feel the Centre needs to amend Drugs and Cosmetics Act to give more powers to deal with such cases?
Section 18 of the Drugs and Cosmetics Act gives a wide ranging powers. Yes, a simple amendment will be useful to further effectively deal with on line sale of prescription drugs. Self medication should never be practiced. Certain checks and counter balances are essential.
Studies show that in the US and UK they have some on line pharma companies who are licensed by appropriate authorities. There are certain rules and regulations to be followed.
Those companies have licensed pharmacists with them, they have doctors with them. Most important thing is they do not sell medicines without prescription. Similar model can work in India as well.
These are very dangerous trends and therefore unless and until there are counter checks and balances such sale of prescribed medicines should not be practiced. Since the Act does not allow it, FDA had taken the action.
Maharashtra FDA had written to GoI and other states about on line sale of prescription drugs. What is their response?
Telangana state also acted similarly, issued notices to on line e commerce companies and asked them to stop sale of medicines on line. Similar action is being taken in one or two more states.
Do you feel the Centre needs to amend Drugs and Cosmetics Act to give more powers to deal with such cases?
Section 18 of the Drugs and Cosmetics Act gives a wide ranging powers. Yes, a simple amendment will be useful to further effectively deal with on line sale of prescription drugs. Self medication should never be practiced. Certain checks and counter balances are essential.
Studies show that in the US and UK they have some on line pharma companies who are licensed by appropriate authorities. There are certain rules and regulations to be followed.
Those companies have licensed pharmacists with them, they have doctors with them. Most important thing is they do not sell medicines without prescription. Similar model can work in India as well.
