Sunday Reading

New Delhi, 30 December 2009

Fake Drug’s scam

NATION’S HEALTH AT RISK

By Suraf Saraf

The Indian public is being looted of thousands of crores of rupees every year without much ado at either the public or legislature level. Worse, none can say since how long, Sadly, it is not a corporate or a bank scandal but one which concerns a vital public matter, involving the question of life and death. The scandal is that of the proliferating business of fake drugs. Till recently the extent of this public loot was being put at about Rs.5000 crores annually. But the most recent estimate puts it at over Rs.17000 crore annually.

While the pharma sector production in India is assessed to be Rs 85000 crores annually, the World Health Organisation (WHO) says that 20 to 25 per cent of this is fake drugs. The Indian companies however, dub it as exaggerated and claim that fake drugs are only between three to seven per cent. Even so, the public loses a whopping amount and in the bargain puts its health in extreme danger.

In the past, the Government had set up a number of committees but the scandal has gone unchecked and reaching such shocking proportions. Observing this mess in the medical system of the country, Union Health Minister Ghulab Nabi Azad has thankfully launched a crusade to root it out. Recently in Parliament, he announced a new health agenda for the nation and spelt out several measures to check the rot.  

The Government, he said would bring the Drugs and Cosmetics Amendment Bill for creating a Central Drug Authority. This will pave the way for making the regulatory mechanism robust. This apart, he sought to bring in a whistle blower scheme under which anyone providing information about the manufacture of spurious drugs would be rewarded up to Rs.25 lakhs. It is thus anticipated that a “Lot many more people will come forward. There will be labourers willing to share information.”   

Additionally, the Ministry proposes to set up special courts for speedy trials for those facing charges. It would engage experienced counsels in the rank of Additional Solicitor General for supervising and contesting such court cases. And, a countrywide survey would be undertaken to know the extent of the scandal. Noting that the law provides for maximum punishment of life imprisonment for spurious drugs manufacturers and a fine of Rs 10 lakhs, Azad said if left to him he would be in favour of capital punishment. However, the menace could be checked even if life imprisonment is awarded to one or two such manufacturers.

The Ministry’s decision to set up an expert group to look into the issue of the cost of medicines is also welcome. Besides, products would be allowed in the market only after approval of experts and that at least one testing lab should be set up in each State. Besides, Azad is also considering roping in private detective agencies and setting up a separate intelligence network to help crack down on defaulters. Other than the drug testing centres, the Ministry may offer rebates in ceiling prices to the manufacturers adapting latest packaging technology to help check the menace.

One may also see a public-private partnership developing in respect of drug testing labs “so that capacity and capability to test the suspected drug samples is on 24x7 basis.” This apart there is a plan to develop a national data bank of manufacturers and products licensed which would be available to field officers.

In all likelihood, the long-pending demand of the pharma industry for having small labs at ports to test basic drug may be accepted. Frequent inspection of off-shore companies, which are registered to judge their quality standard will also be carried out. Fortunately this will not have any additional burden on the Government because as per the Drugs and Cosmetics Act, a foreign manufacturer is supposed to deposit US $ 5000 towards audit of the facilities abroad.

Importantly, the Ministry will be involving other Ministries such as Home, Commerce and Revenue Intelligence in its endevour to check this booming illicit drug trade. Five States-- Uttar Pradesh, Bihar, Maharashtra, Haryana and Himachal Pradesh are said to be the hub of fake drugs. These have “dawa (medicine) bazaars” where one can easily get consignments of fake medicines. The racket is so well-entrenched that criminals have their own line of production and supply chain, particularly targeting the rural areas.

Countering arguments of large presence of fake drugs as indicated by international research agencies and MNCs, the Indian Drug Manufacturers Association (IDMA) claims these account for “below three per cent,” as per the Ministry’s study undertaken by a Hyderabad firm. According to the IDMA “Though there is no specific data on the extent of such drugs, the situation is not as alarming as is made out to be.” 

The Association, which claims support of 650 pharma manufacturers notes that the high figures of such products being available in the market “is false MNC propaganda for obvious reasons. The harshest punishment should be given out to perpetrators of such crimes but then it is not fair to say that Indian pharma manufacturing system is flawed.”

Be that as it may, the Government has now made the offence cognizable and non-bailable. Peddlers of spurious drugs will face life imprisonment or fine of Rs.10 lakhs or three times the value of the drugs confiscated, whichever higher. The fine realized will be paid to the relatives of the deceased. Significantly, scientists violating and conducting unsafe and unethical clinical trials will face imprisonment to five years and a fine of Rs 20 lakhs.

Well, so far the law was very mild. No action could be taken against those who were caught. Now there will be special courts for fast track trials. A provision has also been introduced giving power to the Central government to regulate or restrict manufacturers of drugs in public interest.

However, the number of drug inspectors is woefully short. According to experts it should be one inspector for 60 drug shops but even in the Union Capital Delhi there is only one drug inspector for 550 chemist shops! Imagine what the state of affairs would be elsewhere in the country. This apart, officials at the same time blame the pharma sector for prevalence of spurious drugs as many of the companies are yet to adopt the scientific technology such as bar coding, radio frequency identification chips and innovative packaging designs to check counterfeit drugs.

In sum, despite all these steps and more that may be taken to stem the rot, the big question is will the fake drugs be eliminated from our markets? Let us keep our fingers crossed. Let the polity not forget that health of the people is closely linked with the economic development of the country. ---INFA

(Copyright, India News and Feature Alliance)