Vagueness and doubts about laws in implementation have become source of conflicts between the industry and the regulatory affairs in India. It has to be removed and the laws should be made for cooperation between the industry and the regulatory authorities, said Dr Eric D Kupferberg, Associate Director, Harvard School of Public Health, Boston.
In an exclusive interview with Pharmabiz in Chennai, Dr Kupferberg said that ambiguity in regulations, growing clinical trial market and the increasing number of biotechnology products are the major challenges faced by the country. It seems that enforcement of drug laws faces complicated problems in India and it often becomes headache for the regulatory agency and the DCGI is forced to interpret the laws very often, he said.
In certain areas of implementation this conflict exists in US also, but there is transparency and cooperation in most sides. In the government –industry relation side, India needs cooperation. To create a friendly atmosphere, the enforcement agencies must train their staff in such a way, he said.
Dr Kupferberg was in Chennai to attend the two-day symposium on “Indo-American Pharmaceutical Regulatory Affairs” organized by Sri Ramachandra University.
According to him, India has a large number of manufacturers, big and small, but the country faces shortage of drug inspectors appointed by the central agencies. In US, there are about 2000 manufacturers, but the number of US FDA staff is less than 400, he told Pharmabiz.
Government should prepare a project to train the best pharmacy students to work for regulatory affairs. The DCGI should take the initiative and convince the students to work for the government rather than the industry, because government work is for the entire society. The country needs trained and skilled people for the implementation of drug laws as every new drug is a challenge to be regulated. So the laws should be amended and updated with the emergence of new drugs. Science is advancing compared to the laws of the land. The ministers who handle the portfolios are not scientists. So the implementing officers are to be trained in the modern technology and science, he said.
Further he said US FDA is not acting like policeman and its activities are transparent. It is cooperating with the industry and is made industry-friendly. It really helps the drug companies to work with the FDA as they have many informal meetings. He said US FDA has opened its offices in India also.
When asked how will the US FDA staff act in India, whether they will act like that they do in US or like the regulatory officials of India, he said this is not the time to comment anything on that.