Administration of the act and rules
Administration of the act and rules
A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory – CDL
2)Drug Control Laboratory in states
1) Licensing authorities
2) Controlling authorities
3) Drug Inspectors
Drugs Technical Advisory Board (DTAB)
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii) Director of the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli
(v) Director of Indian Veterinary Research Institute, Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii)Director of Central Drug Research Institute, Lucknow
1) Two persons by the Central Government.
2) One person by the Central Government from the pharmaceutical industry
3) Two persons holding the appointment of Government Analyst under this Act
1) One person, to be elected by the Executive Committee of the Pharmacy Council of India,
2) One person, to be elected by the Executive Committee of the Medical Council of India,
3) One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;
4) One person to be elected by the Central Council of the Indian Medical Association;
5) One person to be elected by the Council of the Indian Pharmaceutical Association;
• To advise the Central Government and the State Governments on technical matters
• To carry out the other functions assigned to it by this Act
Drugs Consultative Committee (DCC)
It is also an advisory body constituted by central government.
Two representatives of the Central Government
One representative of each State Government
- To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act
- The Drugs Consultative Committee shall meet when required
- Has power to regulate its own procedure
Central Drug Laboratory (CDL)
Established in Calcutta, under the control of a director appointed by the Central Government.
• Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts
• Analytical Q.C. of the imported samples
• Collection, storage and distribution of internal standards
• Preparation of reference standards and their maintenance
• Maintenance of microbial cultures
• Any other duties entrusted by Central Government
• Acting as an appellate authority in matter of disputes
The Central Drugs Laboratory
• Provides for the establishment of a Central Drugs Laboratory under the control of a director appointed by Central Government
• The Laboratory established in Calcutta has been entrusted with the following functions
1) to analyze or test samples of drugs or cosmetics sent to it by the cosmetics collectors or courts
2) to carry out such other duties entrusted to it by the Central Government or with its permission, by State Governments, after consultation with DTAB
• The Central Research Institute, Kasauli carries out functions in respect of sera, solutions of serum, proteins for injections, vaccines, toxins, antigens, antitoxins, sterilized surgical ligatures and sutures and Bacteriophages
• Vetenary Research Institute, Izantnagar and Mukteshwar carries out functions in respect of antisera, vaccines, toxoids & diagnostic antigens, all for Vetenary Use
Drug Control Laboratories in State
In Karnataka three laboratories established which collect, analyze and report the various sample of the drugs and food
The laboratory has the following divisions:-
• Pharmaceutical Chemistry Division
• Pharmacology Division
• Pharmacognosy Division
• Food Division
• Ayurvedic Division
• Testing of drug sample
• Analysis of food sample
• Analysis of excise sample
These officers are appointed by the central or state government and perform the duties
• State Government by notification in the Official Gazette, appoint persons having sufficient qualifications to be government Analysts for such areas in state & in respect of such drugs and classes
• Central Government may also similarly appoint Government Analysts in respect of such drugs or classes of drugs or cosmetics as specified
• No person having any interest in the import, manufacture or sale of drugs or cosmetics or is directly or indirectly engaged in any trade or business connected with manufacture of drugs can be appointed as Government analysts
• A graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University and have 5 yrs post graduate experience in testing of drugs in a laboratory under the control of 1)a Government Analyst or 2) head of approved Institution or testing laboratory.
• A Post Graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University with at least 3 years of experience in the testing of drugs in a laboratory under the control of 1)a Government Analyst or 2) head of approved Institution or testing laboratory.
Duties of Government Analyst
• Analyze or test samples of drugs/cosmetics sent to him by inspectors or other persons under the act and to furnish reports of the results of test or analysis.
• Forward to Government from time to time, reports giving the results of analysis works and research with a view to their publication at the discretion of Government.
• On receipt of package of sample from an Inspector the Government Analyst should compare the seals on the package with the specimen seals and note its condition. On completion of test, reports in triplicate together with full protocols of the tests or analysis should be sent to the Investigator.
• Government Analyst has to submit a report in form 1 and unless full protocols are supplied, the report cannot be regarded as conclusive evidence.
• (i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and
• (ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors
• to inspect all establishments licensed for the sale of drugs within the area assigned to him;
• to satisfy himself that the conditions of the licenses are being observed;
• to procure and send for test or analysis, if necessary, imported packages.
• to investigate any complaint.
• to maintain a record of all inspections made and action taken by him in the performance of his duties,
• to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act;
Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law and experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years
1. Persons qualifying for appointment as government, as Governmental Analysis for allopathic drugs; or
2. having a degree in Ayurveda, Siddha, or unani system and not less than three years of post-graduate experience in the analysis of drugs in a laboratory under control of
(a) a government analyst,
(b) a chemical examiner,
(c) head of an institution specially approved for this purpose.
a) Inspect, —
(i) Any premises where in any drug or cosmetic is being manufactured.
(ii) Any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed;
Take samples of any drug or cosmetic,–
(i) Which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;
(ii) From any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee.
Appointed by Central and State Governments.
He should be a person with out any financial interest in the import, manufacture or sale of drugs or cosmetics.
They are deemed as public servants and are officially subordinate to the Controlling Authority.
For appointment as DI, person must have a degree in Pharmacy/Pharmaceutical Chemistry/Medicine with specialization in Clinical Pharmacology/Microbiology from a recognized University;
For inspection of manufactured substances in Schedule C, the DI must have 1) at least 18 months experience in manufacture of at least one of the substance specified in schedule C 2) at least 18 month experience in testing one of the item in schedule C 3) gained experience of NLT 3 yrs in inspection of firms manufacturing any of the substances of Schedule C during their tenure as services as DI
Powers of DI
He can Inspect
any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and testing the drug or cosmetic;
any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ;
Take samples of any drug or cosmetic
which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;
from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee;
At all reasonable times with necessary assistance
search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence relating to manufacture sale or distribution has been, or is being, committed; or
q enter and search any place in which he has reason to believe an offence relating to manufacture, sale or distribution of drugs or cosmetics has been, or is being committed; or
q stop and search any vehicle, vessel, or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence has been, or is being, committed, and order in writing the person in possession of the drug or cosmetic not to dispose of any stock that of for a specified period not exceeding 20 days or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article using which the offence has been ,or is being, committed
q examine any record, register, document or any other material object with any person or in any place mentioned above and seize the same if it is likely to furnish the evidence as an offence
q require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution of any drug or cosmetic with respect to which an offence has been committed
q exercise such other powers as may be necessary for carrying out the purposes of the Acts or Rules.
Duties of Drugs Inspectors
A) Inspection of premises licensed for sale:
§ Inspect NLT twice an year all establishments licensed for sale of drugs within the area assigned to him and to satisfy himself that the conditions of license are being observed.
§ Procure and send for tests or analysis, if he has reason to think that the drugs are sold in contravention of provisions of Acts or Rules.
§ To investigate any complaints made to him in writing & to institute prosecutions in respect to the breaches of the act.
§ To maintain all records of inspections made & actions taken by him including taking of samples and seizure of stocks & to submit copies of such records to the Controlling Authority
§ To make enquiries and inspections as may be necessary to detect sale of drugs in contravention to the Act.
§ When so authorized by State Governments to obtain imported packages which he has reason to suspect to contain drugs whose import is prohibited.
B) Inspection of Manufacture of Drugs
Ø Inspect NLT twice a year all premises licensed for the manufacture of drugs within
the area allotted to him and satisfy himself that the condition of license and provisions of Acts and Rules are observed.
Ø In establishments licensed to manufacture products specified in Schedule C and C1 inspect the process of manufacture, means employed for standardizing and testing of drugs, methods & place of storage, technical qualifications of staff employed & all details of location, construction & administration of establishment likely to affect the potency or purity of drug.
Ø To send controlling authority after each inspection a detailed report indicating conditions of license & provisions of Acts & Rules which are being observed & which are being not observed.
Ø To take samples of drugs manufactured on premises & send them for test or analysis.
Ø To institute prosecutions in respect of breaches of Act and Rules.
Procedure for Drug Inspectors
Ø An Inspector taking any samples must pay its fair price & may require written acknowledgement for the same. If price tendered is refused or when Inspector seizes any stock of any drug or cosmetic, he should issue the receipt for the same in prescribed form. (Form 16)
Ø He should inform the concerned person, the purpose of taking the sample in form 17 & divide the sample to four parts In his presence. Each portion is then sealed & suitably marked. The person from whom the sample is taken must also be allowed to add his mark of seal on the packet. If sample taken from a manufacturing premises, it should be divided to three portions only.
Ø The sample if made into small volume is likely to deteriorate, Inspector can take three or more containers when necessary after suitably marking it.
Ø One portion of sample is to be restored to the person, second part send to Government analyst and third one is preserved for production before the court, if required & fourth is sent to warrantor if any.
Ø Inspector should send the sample to the Government Analyst by registered post or by hand in a sealed packet enclosed together with a memorandum in Form 18 in an outer cover addressed to the Government analyst.
Ø If the confiscated drug is not of standard quality, it should be reported to court accordingly & court may order destruction of drug under the supervision of Inspector in presence of such authority that the court may prescribe.
Ø If confiscated drug is of standard quality, Inspector may report court accordingly and court may order sale of drugs by public auction to any party holding a requisite license.
Ø Any record, register or any other document sized by the Inspector should be returned to the persons from whom they where seized or who produce the same within a period of 20 days of such seizure or produce.
Ø When an Inspector seizes any record, register or document, or any other material object, he should as soon as inform the same to the judicial magistrate & take his orders to the custody thereof.
Ø Every person for time being in charge of any premises where any drug or cosmetic is manufactured or is kept for sale or distribution, on being required by the Inspector is legally bound to disclose to the inspector the place where drug or cosmetic is being manufactured or kept.
Ø Willfully obstructing the Inspector or refusing to provide any record or register is punishable with imprisonment up to three years, or with fine or both.