ASLEW of regulations introduced by the Union Government will enhance the compliance records of the Indian pharma industry, noted Dr. BR Jagashetty, National Advisor, (Drugs Control), and Project incharge for the implementation of two schemes of Central Drugs Standards Control Organization (CDSCO).
These new regulations are formulated to strengthen the Indian pharmaceutical sector. Specific to the draft Drugs & Cosmetics Act (Amendment) Bill 2015 which is now before the industry and related stakeholders for comments, not much can be said at the moment. However, the industry should view the new norms as a stimulus for growth, he added. The recent reforms includes uniform code for pharma marketing, formation of task force to formulate bulk drug policy, introduction of medical devices policy, creation of price monitoring and resource units in the state drugs control department departments and the Draft Drugs & Cosmetics (Amendment) 2015.
“The regulations that are already enforced and those to be imposed signals the opportunity for Indian pharma across the large, medium and small industries to adopt changes and succeed in the competitive market conditions,” said Dr. Jagashetty. As the national advisor, he views the draft Drugs &Cosmetics Act (Amendment) Bill 2015 as a chance for the industry to comment and deliberate about the norms.
Among the interesting inclusions in the draft Drugs &Cosmetics Act (Amendment) Bill 2015 is the penalty clauses for conducting clinical trial of any drug or investigational new drug or any notified category of medical device or investigational medical device without permission. There is also penalty for repeat offence.
The draft Drugs &Cosmetics Act (Amendment) Bill 2015 also indicates penalty for conducting clinical trials in cosmetics without permission will bring in the required systems in place. Besides, there are hefty fines and convictions of an offence which will be punishable with imprisonment for a term which shall not be less than three years but which may extend to seven years and shall also be liable to fine which shall not be less than Rs five lakh. There are also hefty fine for violations amounting to Rs.50,000 and Rs.5 lakh proposed on chemists and druggists.
“The penalties indicate that both pharma industry, clinical research organizations, medical device sector and pharmacy trade will not be able to exploit and indulge in unfair practices. It will now ensure the industry at large will be engaged in productive endeavours, bring in transparency and accountability. This in in-turn will give foreign investors the confidence in India or opt the country for contract research and manufacturing services,” said Dr. Jagashetty.
Another key aspect of the draft Drugs &Cosmetics Act (Amendment) Bill 2015 is the delegation of power of Central Licensing Authority(CLA) and State Licensing Authority(SLA) under Schedule III. The CLAnow replaces the Central Licensing Approved Authority (CLAA). We now need to see how the state drugs control departments accept the CLA, he said. The central government will have the powers to suspend or cancel any permission, licence or certificate issued by CLA or SLA. “This is an important facet in the draft Drugs &Cosmetics Act (Amendment) Bill 2015 primarily because of its reinforcement in the administration,” he said.
Commenting on the Medical Devices Policy, Dr. Jagashetty said that it was vital to also include the medical devices in the draft Drugs & Cosmetics (Amendment) Bill 2015 because these are related to patient care. Further the draft Drugs & Cosmetics (Amendment) Bill 2015 specifies the insertion of a new section 34AAA which states “ any one engaged in imports, manufactures, stocks, sells, or distributes, or intends to do so, any drug or cosmetic or notified category of medical device and submits misleading or wrong information or refuses to provide correct information in that regard as required by the Licensing Authority under this Act would be punishable with imprisonment for a term which shall not be less than two years and be also be liable to fine which is not less than Rs. 1 lakh.”
“The creation of a Medical Devices Technical Advisory Board to advice the government on the technical matters related to the medical devices which includes in-vitro diagnostics is seen indispensable in the current context with latest advances in the healthcare space,” noted Dr. Jagashetty. Although, the government came out with a medical policy, it is to permit 100 per cent foreign direct investments(FDI) in medical devices sector through the automatic route, the need to monitor the sale and manufacture is to be mandated in the draft Drugs, Cosmetics and Medical Devices Act (Amendment) 2015, he said. The enforcement of a Uniform Code of Pharmaceutical Marketing Practices (UCPMP), issued by the Department of Pharmaceuticals from January 1, 2015 is the best thing that could happen in the health sector.
“The fact is the growing unethical practice prevailing in the medical and pharmaceutical space. Drugs should not be promoted but doctors should be educated on its benefits. Bribing medical practitioners by the pharmaceutical companies should be dealt with severity, said Dr. Jagashetty who has been pressing the need for a swift implementation of prescription audit by the Ministry of health across the healthcare space to ensure control of indiscriminate medicine consumption not to just prevent multidrug resistance but also control medical expenses. “This would be the first step for the execution of the Planning Commission mandate of Right to Heath (RTH) on similar lines that of Right to Information (RTI) and Right to Education (RTE).”
The setting up a price monitoring and resource units (PMRUs) in states and Union Territories will help to successfully track violations of drug prices fixed by National Pharmaceutical Pricing Authority. Such a concept has been found wanting up to this time. A few years ago, Karnataka had made an effort to create a unit to monitor pricing violations which did not take off. The formation of PMRUs will now put in place a mechanism for price audits, he said. The Indian bulk drug industry also needs a dedicated policy. This is because active pharmaceutical ingredients (APIs) are the most important contents in a formulation. Therefore the formation of a Task Force to formulate a policy is a step in the right direction by the government, said the National Advisor.
Pharmaceuticals is a priority sector for the country. Aslew of regulations was found wanting and the government knows that the pharma industry is among its key growth propellers and went ahead to unveil the much wanted regulations, added Dr. Jagashetty.