Can Viswaguru overcome this?
(Dr N. Khaleel)
It is common to consult a doctor and get relief from any kind of health problems, starting from feeling weak in the body to getting relief by using appropriate medicine. But if there are medicines like, people’s lives are left as a lamp in the air. Not all pharmaceutical companies can be called, but the way some companies are trying to make profits from the export of substandard medicines is hurting the reputation of our country.
It is heartening to note that the Central Government has resolved, at least of late, to take concrete steps in this regard. The Centre has decided to agree to release the products only if it is confirmed that good practices (GMP) are being followed in the manufacturing process and the guidelines in this regard will be issued soon. Two months ago, Union Minister of State for Energy Bhagwat Kuba had announced that the country has become the ‘Vishwaguru’ of pharma products.
But there have been instances of tens of thousands of people dying due to the use of drugs exported from here. At least 70 infants died after consuming a cough syrup in the African country of Gambia, while 19 children died in Uzbekistan. The US has also declared that the standards of some of the medicines from India are not up to the mark.
Sometimes there are complaints that medicines contain chemicals beyond the dosage and sometimes do not meet the prescribed standards. In such cases, the medicines sent are being sent back. In fact, the cough medicine exported to the Gambia has been banned for sale in our country! Yet it reached the Gambia uninterruptedly. The reason for this plight is the lack of coordination between various government departments. The sooner it is corrected, the better.
The task of the regulatory systems is to check whether the raw materials used in medicines are standard or not, whether they are within prescribed parameters, and to determine whether the product is in line with the statement made that it provides relief from the disease. There are up to 38 such institutions in our country. Apart from the Central Drugs Standard Control Organisation (CDSCO), there are drug testing centres (CDLs) at various places in the states. But it has been proved many times that nothing is being implemented properly.
Maiden Pharmaceuticals in Haryana has produced cough and cold drugs that killed infants in the Gambia and later in Uzbekistan. The company has often faced similar allegations. The company announced on its website that its factory was accredited by the World Health Organization, but it turned out that it was all right. Yet no regulatory department has been able to take action against the drug company. It would be good if the GMP, which is now being implemented, can be implemented properly.
If the manufacturing process is not in order, those products will be damaged within a few days. Even if the medicines do not reduce the disease, there is a lot of cures, but what if it takes life?! In fact, malnutrition, air pollution, poisoning, etc., are playing with people’s lives. If even medicines are added to the list, what else can be said?
In fact, the GMP system for exported drugs has always been in place. But there is negligence at every step of the way in implementing it. Four months after the Gambia tragedy, the World Health Organization (WHO) said that every country that wants to export medicines must ensure that its pharmaceutical companies are implementing specific standards. Some guidelines have been issued for this purpose.
The essence of these guidelines is to see if everything is in order, from the quality of the raw materials to the cleanliness maintained by the surroundings, machines, and staff in the factory. The World Health Organization (WHO) has called for the formulation of the necessary model for recording the procedures followed at every stage of the production process, and to ensure that all this is implemented properly with rigorous checks.
The GMP to be announced by the Centre will now be applicable to medicines sold in our country as well. That’s good. However, if the same laxity about exported medicines is seen here, the intended objective will not be fulfilled. Patients should be convinced that every medicine that comes out of the factory is the most authentic. This is difficult to achieve unless changes are made in the drug inspection procedure.
There are about 30,000 pharmaceutical companies in our country. The existing staff is not enough to check them properly. So, the focus should also be on new appointments. Also, many pharma companies are not making public the details of the experimental results of their products. Such tendencies, which do not follow any transparency at all, are drowning. This situation will change only if the pharmaceutical sector is completely cleansed.
