In the recent past, the pharma Industry has seen a tremendous development after the IT revolution in India though there have been a concern in the matter of hike in new drug patent fees, clinical trial guidelines, new drug price control order and lack of proper functioning of drugs control department. To cope with the ever challenging demand from this industry the concerned authorities have been compelled to make a better regulatory mechanism. At present, the CDSCO and the FDA in some states are looking up to the cause, which is highly insufficient. Moreover the Drugs and Cosmetic Act & Rules 1948 and Pharmacy Act 1950 needs comprehensive amendments owing to which the Government of India (GoI) has plans to introduce the Drugs and Cosmetics (Amendment) Bill, 2013, which seeks to create the Central Drug Authority (CDA) as a centralised licensing authority for drugs during the current session. As recommended by the Mashelkar Committee, a CDA needs to be set up. This authority would review the issuance of licenses for manufacture and sale of drugs. Once this authority is in place, suitable strengthening of its infrastructure and laboratories would be done. The government would mandate that labels on drugs and food fully disclose all its ingredients.
There are several drugs which come under Schedule-H and have been used in the OTC products/drugs. Some of these drugs are to be suitably shifted to some other Schedule. In the context of misuse/drug abuse and marketing of spurious drugs in the market, the present scenario of drugs control department/unit in almost every state needs a revamp. Unless and until there is a strong regulatory authority, it is very difficult to control and penalise the defaulter. The pharmacist can play a very vital role in the healthcare sector in India viz the regulatory authority in the capacity of drugs inspector to drugs controller. If such a set-up is being established in every state it would create ample opportunities for the aspiring graduate pharmacist who at present has a very low scope job opportunity in government organisation. The utmost beneficiary will be the common people who thrive on good government policies. And if the regulatory reforms are implemented in a precise manner, the Indian pharma sector will become much more cleaner and stronger and this will have a positive impact in the overall development of the healthcare sector in India.
– Abhay Kumar, President, Indian Pharmacist Association
