JOIN USThe regulatory authority is entirely responsible for the prevalence of sub-standard drugs in any country. If the mechanisms are good enough, then chances of such drugs circulating in the market will be minimal.
If the regulatory policies in any country are good, tight enough, implemented properly and updated regularly, chances of that country having fake drugs are less. The underworld also plays a major role in it .
Tamil Nadu has set an example in drugs regulation after it formed the TN Medical Service Corporation which buys medicines needed for the entire state. It picks up drugs randomly for checkup . If any company is found to have spurious drugs, the name of the company and the drugs are put on TNMSC website. The company involved knows it gets a bad name. There is also the issue of exports.
India should be proud that we are a leader in the supply of medicine to the world. India has made a great name. But most MNCs are unhappy with what India has achieved. European and American drugs companies have tried to suppress generic companies of India.
As large amounts of medicines are exported to USA, it has set up an FDA office in India, which is the second largest in the world. But we need to achieve higher standards in our quality. Why is it that Indian regulatory authorities are not updated and not having quality control methods tightened?
The type of regulatory mechanism we have depends on the type of political set up we have. Political will is required to achieve higher standards. If the politicians and rogue companies are hand in hand, you cannot expect quality medicine in the market.
About big companies not adopting FDA norms: ultimately, it depends on the drugs ontrol authority. If there is a fake drugs in the market, and that company makes the same brand as I am making, the question is not if it is a big company or small company. It is a rubbish argument. The question is of regulatory mechanism. Why such things do not happen in US and Europe?
As regards campaign by MNCs against Indian drugs, yes, it is indeed there. Our laws may be hurting them and they blame entire India.
There is also a long battle between generic drugs firms and MNCs mainly because of the costs involved. MNCs say their cost is higher because of research. Whatever the cost involved, MNCs are interested in making drugs like Viagra, for obesity and not for malaria or TB. Will they address public health problems of my country?
(Dr Dabade is Convener, All India Drugs Action Network)