"One out of four is a fake" was the screaming headline in a popular weekly. Reading this headline, the first thought, which came to mind, was " how can people get away by publishing such irresponsible articles. This will destroy the faith people/doctors have in the manufacturers in India".
Normally manufacturers go through pains in building systems ensuring quality products are made available and to make sure that all steps are taken to produce drugs of proper quality both from regulatory and manufacturers angle.
However, after reading through the article one might think atleast about 20-25 per cent of the national turnover are coming from sale of spurious drugs. However, the headline of "one out of every four is a fake" though a figure of speech, has some truth.
It is not important to argue whether the percentage is "less" or "more". We are saddled with the fact that "There are spurious drugs".
Let us for a minute assume it is about 5 per cent. It is still dangerous because if things are left as they are, we are going to see a 10 fold increase.
It is a pity that even in the matter of "life and death" human mankind has risen to a level of profiteering from irreversible loss of life of fellow humans. The nature of the people involved in this activity must be like the mind of a "hardened criminal" who are prepared to trade life for money even if it is the life of his own kith and kin.
Under these circumstances Mashelekar committee's recommendation of "death penalty" is justified and appropriate.
While this is acceptable, adequate provisions should be made to ensure that Manufacturers who by "accident" and "unintentionally" get involved or accused do not get punished.
If we accept the "death" penalty, the responsibility of the Inspectorate, testing labs and government analyst increases enormously. We should first look into sampling procedures, conditions of transportation and storage, availability of proper methods of testing, equipment in a validated state and reference standards and a very high level of GLP and expertise are available in the laboratories. These labs should be able to pass International WHO Audits. The speed of communication and infrastructure in the total chain is very pertinent.
The above improvements have to be taken up on a "war footing" to coincide with the proposed enactment of "death penalty".
In addition to the "legislation" and "Infrastructure", we also need to attack the problem "per se". Spurious & Counterfeiting is not exclusive to India. Even in advanced countries like USA it is estimated to be about 5 per cent of the sale of the drugs.
This aspect of spurious drugs is largely prevalent in
1. Popular brands.
2. Generic drugs purchased by Quacks and Institutions (supplied through agents).
3. Exports - Especially, "trader" generated orders.
The problem is more prevalent in India (and in other developing and under developed nations)
for drugs due to the following reasons:
1. The inherent nature of the business i.e. the actual consumer (patient/doctor) is many stages away from the Manufacturer. It is important that the consumer / Manufacturer / Regulator has a better control over the "Supply Chain" to reduce this "menace".
2. Too many Manufacturers (official licensed about 20,000).
3. Inadequate infrastructure for easy transportation and communication.
4. Growing "Apathy" of the consumer / trader / and even Regulatory authorities.
5. Lack of suitable legislation and Political "will" to end this menace.
It is also very difficult to detect the counterfeits / spurious drugs. The major groups of people who can reduce this menace are as follows:-
A.Government
B. Regulatory
C. Manufacturer
D. Distributor
E. Consumers (Public)
Assuming that government, judiciary and regulators are doing their best, let us see in what way Manufacturers, trade & public can contribute to alleviate the problem.
Let us examine some of the primary aspects which are helping the proliferation of "spurious" and "counterfeit" drugs in India and the possible solutions.
The suggestion of authenticating the shippers is a novel tool detect counterfeiting. It may sound impractical, but it can be done. If this is being done for Credit Cards, why not Drugs. We only may need a PC terminal at wholesalers. Almost 50 per cent already have and for others the companies can facilitate this.
The "spurious" drug menace should be dealt with in all seriousness before it is not too late to prevent " blacklisting of the country" and also be confident of treatment received by one's own kith and kin.
-- The author is Executive Vice President, Banner Pharmacaps (I) Private Ltd. Bangalore