Submitted by Niklesh Rao V on Fri, 11/06/2009 - 18:14.
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.
original article by: K.Subbi Reddy,Assistant Director, Drugs Control Admn, Regional Office, Rajahmundry, E.G.Dt. A.P.
source:pharmabiz.com
"Ability is what you're capable of doing...
Motivation determines what you do...
Attitude determines how well you do it."
Regards,
V Niklesh Rao www.pharmainfo.net/nik
Submitted by Niklesh Rao V on Fri, 11/06/2009 - 17:38.
All regulatory aspects related to import, manufacture, sale and advertisements of drugs in India are covered under three separate enactments, namely, Drugs & Cosmetics Act 1940 and the Drugs & Cosmetics Rules 1945, The Pharmacy Act 1948 and the Drugs & Magic Remedies (Objectionable Advertisements) Act 1954.
Drugs & Cosmetics Act
The Drugs and Cosmetics Act 1940 is a central legislation, which regulates the import, manufacture, distribution and sale of drugs and cosmetics in the country. The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and conform to prescribed quality standards and the cosmetics marketed are safe for use. The Drugs Act was enacted in 1940. The Drugs Rules were promulgated in December 1945 and the enforcement of these statutes started in 1947. The Drugs Act, as enacted in 1940, has since been amended several times and is now titled as Drugs and Cosmetics Act. The Rules have also been amended from time to time to meet the needs of the times and to make good any deficiencies noticed during the implementation. The very definition of 'Drug' under the Drugs & Cosmetics Act covers a wide variety of therapeutic substances, diagnostics and medical devices.
Recently, the central government notified 10 medical devices as drugs that requires central clearance prior to import, manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are cardiac stents, drug eluting stents, catheters, intra ocular lenses, I V Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
Under the Constitution of India, 'Drugs' being a concurrent subject, the responsibility of enforcing the various provisions of the Act vests with the Central Government and the State/UT Governments. The roles of Central & State Governments are well defined.
Pharmacy Act 1948
The Pharmacy Act was enacted for the regulation of the profession and practice of pharmacy in the country. The Act has led to the formation of the Pharmacy Council of India (PCI) which regulates the functioning of pharmacy education institutions through state pharmacy councils. PCI is also the statutory body to register pharmacy graduates, thereby turning them eligible for practicing as community pharmacists.
Drugs and Magic Remedies Act talks about controlling the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. State drug regulators are the enforcement agencies of D &MR Act.
Central Drug Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General (India) (DCGI) discharges the functions allocated to Central Government. The CDSCO is attached to the office of the Director General of Health Services in the Ministry of Health and Family Welfare. The DCGI is a statutory authority under the Drugs Act and has port offices, zonal offices and drug testing laboratories functioning under him.
The main functions of the Central Government are approval of new drugs to be introduced in the country, permission to conduct clinical trials, registration and control on the quality of imported drugs, laying down regulatory measures and amendment of Acts and, Rules, laying down standards for drugs, cosmetics, diagnostics and devices, and updating Indian Pharmacopoeia, approval of Licenses as Central License Approving Authority for manufacture of large volume parenterals, vaccines and biotechnology products and operation of blood banks and also of such other drugs as may be notified by Government from time to time. It also coordinates the activities of the States and advising them on matters relating to uniform administration of the Act and Rules in the country.
The State Governments are responsible for licensing of manufacturing establishments and sales premises, carrying out inspections of licensed premises for ensuring compliance to conditions of licenses, drawing samples for test and monitoring the quality of drugs and cosmetics moving in the State, taking appropriate actions like suspension / cancellation of licenses, surveillance over sale of spurious / adulterated drugs, instituting legal action, wherever needed, as provided in the Act and Rules and to monitor objectionable advertisements pertaining to drugs. The State Drug Controllers exercise these functions through State Drugs Inspectors. The organizational set up varies widely from State to State. While in some States, a full time technical person heads the drug con trol Organization, the others have administration or medical persons as ex-officio drug controllers or heads of offices.
Capacity Building Programme
The latest development in the area of drug regulation is the launch of an ambitious World Bank supported Capacity Building Programme. Already underway, the programme envisages the setting up of a world class Food and Drug Administration Headquarters in Delhi. The construction of the Administrative Building is considered as a physical and psychological milestone due to its symbolic significance as the first step for a uniform food and drug administration.
The total cost of the project is about Rs.355 crores of which the multilateral funding agency will provide more than Rs.236 crores. The building itself is to cost Rs.11.74 crores and will be ready in about in 2006.
The Food and Drug Administration Bhawan will house the offices of CDSCO and the Food Division of DGHS, Ministry of Health and Family Welfare. The FDA Bhawan would ensure better interface of Drug and Food Authorities with the public and other stakeholders. The programme also envisages country wide training programmes for regulators, analysts and small scale pharmaceutical companies for better enforcement and compliance of the laws
source:pharmabiz.com
"Ability is what you're capable of doing...
Motivation determines what you do...
Attitude determines how well you do it."
Regards,
V Niklesh Rao www.pharmainfo.net/nik
Submitted by Niklesh Rao V on Fri, 11/06/2009 - 17:37.
Drug regulation is of prime importance to ensure the highest quality of medicines,especially in INDIA. In our country the main drawback for the pharma industry as a whole are the spurious, misbranded and other such fake medications which are flooding the market. It is kind of sad to note that even the vital areas like health regulation are corrupt to a very high degree. As responsible pharmacists and the future of our nation we must strive to tackle this problem. I will in my following posts explain how the drug regulation system works in India and how it may be improved.
"Ability is what you're capable of doing...
Motivation determines what you do...
Attitude determines how well you do it."
Regards,
V Niklesh Rao www.pharmainfo.net/nik
How regulation should be
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.
original article by: K.Subbi Reddy,Assistant Director, Drugs Control Admn, Regional Office, Rajahmundry, E.G.Dt. A.P.
source:pharmabiz.com
"Ability is what you're capable of doing...
Motivation determines what you do...
Attitude determines how well you do it."
Regards,
V Niklesh Rao
www.pharmainfo.net/nik
Drug regulatory system in India
All regulatory aspects related to import, manufacture, sale and advertisements of drugs in India are covered under three separate enactments, namely, Drugs & Cosmetics Act 1940 and the Drugs & Cosmetics Rules 1945, The Pharmacy Act 1948 and the Drugs & Magic Remedies (Objectionable Advertisements) Act 1954.
Drugs & Cosmetics Act
The Drugs and Cosmetics Act 1940 is a central legislation, which regulates the import, manufacture, distribution and sale of drugs and cosmetics in the country. The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and conform to prescribed quality standards and the cosmetics marketed are safe for use. The Drugs Act was enacted in 1940. The Drugs Rules were promulgated in December 1945 and the enforcement of these statutes started in 1947. The Drugs Act, as enacted in 1940, has since been amended several times and is now titled as Drugs and Cosmetics Act. The Rules have also been amended from time to time to meet the needs of the times and to make good any deficiencies noticed during the implementation. The very definition of 'Drug' under the Drugs & Cosmetics Act covers a wide variety of therapeutic substances, diagnostics and medical devices.
Recently, the central government notified 10 medical devices as drugs that requires central clearance prior to import, manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are cardiac stents, drug eluting stents, catheters, intra ocular lenses, I V Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
Under the Constitution of India, 'Drugs' being a concurrent subject, the responsibility of enforcing the various provisions of the Act vests with the Central Government and the State/UT Governments. The roles of Central & State Governments are well defined.
Pharmacy Act 1948
The Pharmacy Act was enacted for the regulation of the profession and practice of pharmacy in the country. The Act has led to the formation of the Pharmacy Council of India (PCI) which regulates the functioning of pharmacy education institutions through state pharmacy councils. PCI is also the statutory body to register pharmacy graduates, thereby turning them eligible for practicing as community pharmacists.
Drugs & Magic Remedies (Objectionable Advertisements) Act 1954
Drugs and Magic Remedies Act talks about controlling the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. State drug regulators are the enforcement agencies of D &MR Act.
Central Drug Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General (India) (DCGI) discharges the functions allocated to Central Government. The CDSCO is attached to the office of the Director General of Health Services in the Ministry of Health and Family Welfare. The DCGI is a statutory authority under the Drugs Act and has port offices, zonal offices and drug testing laboratories functioning under him.
The main functions of the Central Government are approval of new drugs to be introduced in the country, permission to conduct clinical trials, registration and control on the quality of imported drugs, laying down regulatory measures and amendment of Acts and, Rules, laying down standards for drugs, cosmetics, diagnostics and devices, and updating Indian Pharmacopoeia, approval of Licenses as Central License Approving Authority for manufacture of large volume parenterals, vaccines and biotechnology products and operation of blood banks and also of such other drugs as may be notified by Government from time to time. It also coordinates the activities of the States and advising them on matters relating to uniform administration of the Act and Rules in the country.
The State Governments are responsible for licensing of manufacturing establishments and sales premises, carrying out inspections of licensed premises for ensuring compliance to conditions of licenses, drawing samples for test and monitoring the quality of drugs and cosmetics moving in the State, taking appropriate actions like suspension / cancellation of licenses, surveillance over sale of spurious / adulterated drugs, instituting legal action, wherever needed, as provided in the Act and Rules and to monitor objectionable advertisements pertaining to drugs. The State Drug Controllers exercise these functions through State Drugs Inspectors. The organizational set up varies widely from State to State. While in some States, a full time technical person heads the drug con trol Organization, the others have administration or medical persons as ex-officio drug controllers or heads of offices.
Capacity Building Programme
The latest development in the area of drug regulation is the launch of an ambitious World Bank supported Capacity Building Programme. Already underway, the programme envisages the setting up of a world class Food and Drug Administration Headquarters in Delhi. The construction of the Administrative Building is considered as a physical and psychological milestone due to its symbolic significance as the first step for a uniform food and drug administration.
The total cost of the project is about Rs.355 crores of which the multilateral funding agency will provide more than Rs.236 crores. The building itself is to cost Rs.11.74 crores and will be ready in about in 2006.
The Food and Drug Administration Bhawan will house the offices of CDSCO and the Food Division of DGHS, Ministry of Health and Family Welfare. The FDA Bhawan would ensure better interface of Drug and Food Authorities with the public and other stakeholders. The programme also envisages country wide training programmes for regulators, analysts and small scale pharmaceutical companies for better enforcement and compliance of the laws
source:pharmabiz.com
"Ability is what you're capable of doing...
Motivation determines what you do...
Attitude determines how well you do it."
Regards,
V Niklesh Rao
www.pharmainfo.net/nik
Drug regulation is of prime
Drug regulation is of prime importance to ensure the highest quality of medicines,especially in INDIA. In our country the main drawback for the pharma industry as a whole are the spurious, misbranded and other such fake medications which are flooding the market. It is kind of sad to note that even the vital areas like health regulation are corrupt to a very high degree. As responsible pharmacists and the future of our nation we must strive to tackle this problem. I will in my following posts explain how the drug regulation system works in India and how it may be improved.
"Ability is what you're capable of doing...
Motivation determines what you do...
Attitude determines how well you do it."
Regards,
V Niklesh Rao
www.pharmainfo.net/nik
what are the future prospects
what are the future prospects in DRA????