The demand for setting standards of quality of drugs in the country and effective control over their negative effects is a very old one.
In a country where a large population takes medicines from fake doctors and medical stores, there the standardization of medicines becomes very important.
In recent days, the debate about standardization of medicines has intensified after the reported deaths due to cough syrups in countries of Africa and Central Asia.
The comments of the World Health Organization also dented the credibility of the Indian pharmaceutical industry.
Undoubtedly, India’s reputation has also been affected by this episode. It seems that after this the central government also swung into action and took initiative to ensure the production of safe medicines.
It is quite possible that after this development a step has been taken to ensure the production of safe medicines with high standards.
A bill to ensure production of safe drugs is proposed to be introduced in the monsoon session of Parliament.
Through which it can be ensured that the negative effects of substandard medicines on the country and abroad are curbed. Of course, at its core are lessons from the negative effects it has had on people in India and many countries around the world.
For this purpose, the Drugs, Medical Devices and Cosmetics Bill, 2023 is being brought.
Undoubtedly, before giving this bill the form of law, its various aspects will need to be seriously brainstormed. So that the shortcomings related to this industry can be removed.
Undoubtedly, there is a need to develop a reliable pharmaceutical ecosystem in the country. For which research and regulation of quality is also necessary.
The Bill will ensure high standards in the manufacture, sale, import and export of drugs, medical devices and cosmetics. Which will repeal the Drugs and Cosmetics Act-1940 and make the law useful according to the new needs. Before giving this bill the form of law, there will be a need to seriously brainstorm on its various aspects. So that the shortcomings related to this industry can be removed.
In fact, where there are hurdles in the way of determining the quality of drugs, the lobbies of the pharmaceutical industry and political entanglement, the inconsistencies in our regulatory system are also at the root of this. In such a situation, there will be a need to take many precautions while making laws.
It will also have to be seen that the new law does not have any negative effect on the pharmaceutical industry of the states.
Today India has emerged as a major drug producing country in the world. But our priority should be to determine the quality of medicines. It is also important for the country’s reputation. There have been apprehensions that the new law may curtail the powers of state drug controllers with regard to licensing of drug manufacture.
It is pertinent to mention here that efforts to strengthen the Drugs Standard Control Organization have failed twice earlier also. In the years 2007 and 2013, the Drugs and Cosmetics (Amendment) Bill was eventually passed due to discrepancies. were withdrawn by the Parliament. It is noteworthy that in the year 2021, when the new bill was being prepared, the pharma industry of Punjab had expressed objection to the proposed centralization of licensing and other regulatory processes.
Gripped by apprehensions about the future, representatives of around 200 small pharma units in the state worried that they would lack sufficient financial resources to approach central agencies or upgrade infrastructure to meet the changed norms.
Actually, the pharmaceutical industry of Punjab was facing weak competition from the pharmaceutical industry of Himachal Pradesh because the pharmaceutical manufacturing units of Himachal Pradesh were getting the benefit of GST exemption till the stipulated time.
Due to which they were presenting a challenge to the producers of Punjab by selling cheap medicines in the market.
