The proposal to create National Drug Authority (NDA) as an autonomous body is a valid proposition in the globalized scenario, by which the Indian pharmaceutical industry can take a due share in the global market.
A well-established regulatory system will create confidence in the minds of importing countries on the quality management in the production of drugs and pharmaceuticals in India.
It's a known fact that some of the countries like United States and international organizations like the World Health Organization, in their procurement programmes evaluate the manufacturers as well as the regulators. Hence, it is imperative that the Indian regulatory system be upgraded to meet the requirements due to globalization and the growth in the pharmaceutical industry by the decentralized system, which is creating confusion in the minds of importing countries.
They expect exporting countries to have one national level regulatory authority, having total control of all the activities connected with drug manufacturing in the country. Our present system is contrary to the expectations as we have number of states having varying levels of administration. Hence, there is a need to create NDA/CDA that takes the responsibility of the quality of drugs manufactured, within the country and for compliance to cGMPs. Some of the major issues that have to be addressed by the (proposed) National Drug Authority are:
- Lack of Uniformity of Implementation of Drugs & Cosmetics Act
- Monitoring of Adverse Drug Reactions
- Prevalence of Spurious Drugs and
- Exports
- Grey areas, which are not properly defined, monitored and controlled.
Lack of Uniformity in Implementation of D&C Act
The Drugs & Cosmetics Act is a central legislation implemented by various states depending on the strength of the state, organisation, presence of industry in the state. The system followed to monitor the quality varies from state to state. But there is no restriction on the movement of drugs within the country.
Various procedures adopted for licensing of manufacturing premises and products differ substantially, for example the interpretation of a new drug varies from state to state and each state has its own methodology to decide if a drug is a new one or a drug is already in use.
Though, time and again efforts were made to harmonize the licensing procedures. This harmonized system did not give expected results, as State Drug Control Administration is independent from the centres. The global phenomenon is the centralized licensing particularly when there is free interstate movement of drugs. Once a single agency is responsible for licensing, it is particularly feasible to ensure uniformity by prescribing minimum benchmarks and defining SOP for the regulatory systems. But at the same time if the workload of licensing manufacturing facilities from the states have to be shifted to centre, then the centre should be provided with required infrastructure and personnel before making it responsible for the activity.
Approximately about 300 drugs inspectors from various states handle the regulatory aspects of manufacturing activity and now the present strength in the central government is around 30. If the responsibility is shifted without strengthening the central government/National Drug Authority, it will lead to adhoc-ism and shortcuts. A system-based approach and decentralization within the organisation will help effective implementation of provisions of Drugs & Cosmetics Act.
Monitoring of Adverse Drug Reactions
The drugs are introduced in the country after establishing safety and efficacy. But drugs are known to cause adverse reactions -- both known and unknown. An effective system to monitor adverse drug reaction, which is a critical parameter, is essential for assuring safety of drugs in the market. There are enough cases to prove that the drugs which are proved to be safe and efficacious in clinical trials conducted for marketing authorization are proved to be risky and withdrawn from the market voluntarily by the industry or at the directions of the regulatory authorities. At present the monitoring system of adverse reactions is practically non-existent except for limited post market surveillance conducted by the manufacturers as a part of obligation towards marketing authorization granted.
Spurious Drugs
There is lot of difference in understanding of various stakeholders about spurious and counterfeit drugs and the extent of availability in the country. The public doesn't differentiate between counterfeit and spurious drugs, whereas in the eyes of the regulators there are two different categories. To address the problem of spurious/counterfeit drug, it is essential to understand the extent of availability of spurious and counterfeit drugs statewise, through an appropriate statistical sampling technique and also to evaluate the interstate movement of such drugs.
It is of importance to identify the reasons for genesis of spurious and counterfeit drugs and solve the problem with a holistic approach for monitoring and eradication. For this purpose, legislation has to be strengthened and more powers have to be given. A deterrent has to be created for people to be afraid of indulging in activity of manufacture, distribution, and sale of counterfeit drugs. One of the important requirements is creation of intelligence division in each of the state, zone and sub-zone and networking them and providing them with quick testing facilities, infrastructure for commuting, communication and required funds.
Export
Drugs & Cosmetics Act is silent about exports, but as the present system of licensing of drugs meant for export indicates that the control of manufacturing drugs meant for export are the same as that are meant for local market. But in the local market adequate Post Market Surveillance is done to evaluate the quality and punish the culprits, the same is not being followed with, an assumption that it is the responsibility of the importing country to evaluate the quality.
The repeated reports of substandard drug is creating credibility problem of the drug manufactured into the country. NDA should address various issues connected to report and draw system, which will improve the credibility of the Indian Pharmaceutical Industry and the Indian Regulatory System.
— The author is Dy. Drugs Controller (India) West Zone