Powers entrusted by the Law are for implementation of the law for welfare of the Society. Powers delegated either to any organization or to any person without specific responsibilities and accountability leads to various problems. Powers without proper facilities and mechanism create negative effects and add fuel to fire. With this if we analyze the present state of affairs, we understand as follows:
- Structure & Strength
- Present System
- Role of Central Regulatory Authority (CDSCO)
At present, imports, approval/ban of drugs are taken care by CDSCO, which is also acting as CLAA in case of some category of drugs. Latest registration policy is taking care of inflow of bulk drugs but not the other chemicals, which are precursors of bulk drugs. The role of CDSCO in harmonizing and coordinating the inter state Drugs Regulatory Authorities (DRA) is not effective. We are seeing in India that there are hardly a few states trying to implement the Drugs and Cosmetics Act, 1940 and Rules 1945 to the extent they feel correct. There are states where no proper Drugs Regulatory mechanism. This shows we have weakest places of control to moderate places of control on the quality of drugs moving in India. But we do not have any control over the movement of drugs from weak control places to other places except random checking by drawing samples available in the market. (Limitation of analytical facilities).
CDSCO officers are participating in three areas of work with State DRA Officers. 1. Inspection of CLAA category Units with or without State DRA Officers. 2.Drawing of Samples for Analysis in the area of work. 3. Joint Inspection of Mfg. units for issue of WHO GMP Certificates (Non-Statutory). These officers have no responsibility over the happenings in their respective working areas and if any thing happened, they through blame on the local State DRA Officers.
Role of State Drug Regulatory Authority
Implementation of the Act is done by observing the Rules and Guidelines framed.
In most of the states, they are under staffed and no established systems are present. They are technical and professional (Pharmacy) in nature. We cannot expect technical expertise with policing from one person. There are three aspects to be observed by State DRA: 1. Regulate the manufacture of the drugs in their area to meet the specifications and guidelines laid down by the Drugs and Cosmetics Act, 1940 and Rules 1945 2. Regulate the Inter and Intra state Commerce in Drugs 3.Prevention, Control and take steps to punish the offenders. In case of first aspect, most of the states are very week and a few states are implementing, as they like. Some times, they are overlapping in to the authority of DCGI in permitting new drugs. There are hardly any regulations or control over the mistakes or offences committed by the State DRA Officers who permit even manufacture banned or new drugs. Except Maharastra and Gujarat, all other state DRA's are not strong in respect of finance or mechanisms or facilities provided by the State Governments. The budget allocated to DRA in any state is not even 0.4% of their health budget. In this, nearly 86% is going to the staff salaries and only 10% is going to be spent for actual work. States are not showing much interest in implementation of this Act and Rules as it is a Central Act. Any happenings are threatening to the existence of their continuity (political) then only they are showing concern for implementation of this act. In many States, Local political personal are trying to interfere in the implementation of this Act and rules. Local persons are influencing the DRA officers and the bad activities in this field are posing threat to the nation's health in the form of spurious / adulterated etc. drugs. In view of this, some of the category of drugs manufacturing licenses is getting approved by CLAA
Disposal of cases detected: There are two aspects in implementation of Drugs and Cosmetics Act, 1940 and rules 1945 in India. As and when any offence is detected in a licenced premises, the concerned drugs control authority is taking departmental action like suspension or cancellation of licences granted to the premises or to the persons, closing the file and let off them. If the offence is gross in quantity or in quality, the concerned licenced persons are prosecuted under the law. If the dealer is not a licencee or the premises is not licenced to use, then the concerned drugs control authorities are initiating legal action in the court of Law.
Is it necessary to follow legal procedure (filing a case in court of law) for any violation detected under the Act and Rules ? If yes, there will be thousands of cases arise out of the implementation of Drugs and Cosmetics Act, 1940 and Rules 1945.
There are state amendments in the Act and which differentiate the same crime in one state to other state. The Drugs and Cosmetics Act and rules should be one for entire country to control the quality of Drugs. The committee may through light on the above matter and recommend to amend the Act and Rules accordingly.
Modifications Suggested
1. There should be one National Drug Authority (NDA) with Powers, Freedom and Responsibilities to control the quality of drugs in India. 2. There should be one Act for entire country to control the quality of drugs 3. The Act and Rules should be implemented by one organization or one system of organization uniformly in the Country. 4. Pharmacy and Drugs sail together and they cannot be separated. National Pharmaceutical Services may be created to serve NDA on par with other Indian Services. Only under one umbrella, the administration should serve the country and assure the safety of drugs moving in Indian markets. 5. All eligible officers of all state Drug regulatory systems may be taken into the services of Center and assign the local category to their respective states to work in the NDA. 6.Upgrading all State Drugs Testing Laboratories and set up electronic network for effective functioning under the control of Central Drugs Laboratories whose director will report to NDA. 7.There should be one national electronic network to join all state drug regulatory authorities and regional drug authorities with data bank on drugs available in India with their pharmacological and technical details. 8.NDA may be designated as national authority to monitor the Adverse Drug Reactions in India. The Act and rules may be modified to report all adverse drug reactions resulting grievous hurt and above by the concerned medical officers to the local NDA officer and obtain acknowledgement. 9.It should made mandatory to submit information by all ancillary industries to Pharmaceutical industry about the supply of materials and machinery made by them to the local NDA officer concerned to control the manufacture of spurious drugs. 10.Designated Courts in each region of State may be established for speedy trial and disposal of cases.
Why one organization should administer the Central Act and Rules in India?
1. The subject " quality of drugs " require professional approach and it is national importance. Drugs are needed in all walks of life to improve one's own life. An healthy person can only build a healthy nation.
2. India is a vast country with diversity with a concept of Unity. Political scenario is getting changed in any state without much time. Various political parties are coming up in different states with different policies, which are highly local in nature. Health and Drugs is one subject, which require broad and wide approach. Even World Health Organization, Unicef etc., are trying to coordinate even the efforts of countries to contain diseases. Day-by-Day new diseases are coming up and threatening the human race. Drugs are getting limited and they require larger attention to put them into optimum use. Indiscriminate use of drugs is to be controlled to prevent recurrence of diseases and development of resistance to microbes.
3. Still, majority states are not set up their proper regulatory network to safe guard the movement of quality drugs.
4. Present drugs regulatory officers in few State Governments are less in number and they can be absorbed into central services as their duties are technical and professional in nature.
5. Local influence should be controlled on the production of the quality of drugs.
The structure of NDA in the country is proposed as follows:
National Drugs Regulatory System (NDRS) or Indian Drugs Regulatory System (IDRS)
National Drug Authority (NDA): Looks after overall control of drugs moving in the country and directly reports to PM/President of India. His decisions are going to affect the health of nation. Safeguarding the Health of Nation is as important as that of Armed Forces. He approves news drugs and directly supervises the adverse drug reactions reported. He should submit annual report on the quality of drugs moving in Indian Markets and his organization overall performance.
Regional Drug Authority (RDA): Reports to NDA and coordinate all SDC. They are licencing authority for certain category of drugs.
State Drug Authority in the rank of secretary (SDA): Directly reporting to NDA under intimation to RDA. They are responsible for the affairs in their respective states. They are licencing authority for manufacture of drugs in their state. They are controlling authority of all officers working in the State.
State Regional Vigilance Officer (Drugs): He must be a police officer with the rank of S.P. in CBI with supported staff and facilities to carry criminal investigations on par with CBI. There should be one officer for three to four Districts in a State.
District Drug Authority: He is in the rank of I.Ph.S. (Indian Pharmaceutical Services) or Assistant Director and supervise the performance of the officers of Drugs working in his area. Directly reporting to SDA and licencing authority of all distribution outlets of drugs in his area.
Officer of Drugs / Drug Officer: S/he must be a gazetted officer. Perform all the basic functions in the organization. His job is highly technical and professional. He is in charge of the area allocated and responsible for the affairs arising out in that area. He will register FIR in all criminal cases arising out of the implementation of Acts of Drugs in the concerned Police Station and the same will be transferred/referred to SRVO (Drugs) for investigation and for proper action.
-- The author is Assistant Director, Drugs Control Admn, Regional Office, Rajahmundry, E.G.Dt. A.P.