Inspector

Inspector

The Drug Inspectors are appointed both by State Government and Central Government for specific areas or for specific category of activity. There could be a set of inspectors exclusively for the manufacturing of drug formulations. Drug Inspector works under the Drug Controlling Authority under State Government or Central Government as the case may be. An inspector has been charged with the responsibility of ensuring strict implementation of Drugs and Cosmetics Act in the area of his/her. jurisdiction.

(i) Qualification for Drug Inspector

The person should not have direct or indirect financial interest in any of the activities concerned with import, manufacturing, sale or distribution of drugs.

A graduate in pharmacy or pharmaceutical sciences or medicine with specialization in clinical pharmacology or microbiology from a University established in India, is eligible for the post of Inspector.

For the purpose of Schedules C and C (1) drugs, (i) a drug inspector with atleast 18 months of experience in manufacturing of atleast one substance specified in Schedules C and C (1) or (ii) a drug inspector with atleast 3 years experience in inspecting the firms manufacturing Schedules C and C (1) drugs or (iii) a drug inspector with minimum of 18 months experience in testing of atleast one ofthe substances in schedules C and C (1) in a laboratory approved for the purpose.

The requirement of these qualifications shall not, however, apply to those persons appointed as Inspector on or before 18^th October, 1993.

Every Inspector shall be deemed to be a public servant under Section 21 of the Indian Penal code.

(ii) Duties of Inspectors of Premises Licensed for Sale

Subject to instructions of Controlling Authority, it shall be the duty of an Inspector authorised to inspect premises licensed for the sale of drugs.

(i) to inspect, not less than once a year, all establishment for sale.

(ii) to satisfy himself that conditions of licences are being observed.

(iii) to procure and send the drug for test or analysis if he has reason to suspect that drug is sold or stocked in contravention with provisions of the Act or Rules.

(iv) to investigate complaint in writing.

(v) to maintain a record of inspections.

(vi) to make necessary enquiries.

(vii) to institute prosecutions in respect of breaches of the Act and Rules.

(viii) when authorized by the State Government, to detain imported packages which he has reason to believe contain drugs, the import of which is prohibited.

(iii) Duties of Inspectors Specially Authorised to Inspect Manufacture of Drugs or Cosmetics

Subject to instructions of Controlling Authority, the following duties are performed:

(i) to inspect, not less than once a year, all premises licenced for manufacture of drugs or cosmetics

(ii) to satisfy himself that conditions of licence are fulfi lIed.

(iii) to inspect plant, process of manufacture and standardization, storage, technical qualifications and other details for Schedules C and C (1) drugs.

(iv) to send detailed inspection report to Controlling Authority.

(v) to take samples for test or analysis in accordance with Rules.

The Inspector, except for official business or when required by law, shall not disclose any information acquired by him.

If he has sufficient reasons to believe that violation of provisions of DCA is taking place, he/she may and seize records or ask the manufacturer not to sell the drugs for a period of 20 days.

Drug Inspector if required may take the xerox copies of the seized documents signed by the owner of the documents.

Drug Inspector is supposed to carry a routine inspection atleast once in a year of a shop or a manufacturing unit within his area. The inspection should be generally carried out at reasonable time preferably during working hours. However ifhe/she has sufficient reasons to believe that contravention ofthe provision of DCA is taking place he/she accompanied by sufficient force may raid the premises and seize the documents, records or the medicines as the case may be.

The sample withdrawn or seized from drug store should be divided into 4 parts. The seizure of medicine should be carried out in accordance with the Code of Criminal Procedure, 1898 in presence of witnesses. The samples should be sealed and the seal of drug store owner should also be allowed. In case of injectables, 4 different ampoules of same batch are seized. The payment of fair price of seized material is made to the drugs store owner or in case of refusal for accepting money, the receipt is prepared by Drug Inspector separately and the form is filled up. Any action of seizure or raid is required to be informed to Judicial Magistrate of that area immediately. Out of 4 samples confiscated, one is retained by the Inspector, one is sent to Government analyst, one is given back to drugs store owner and 4th sample is sent to the manufacturer.

The sample sent by an Inspector to Government Analyst shall be by registered post or by hand in sealed packet enclosed with memorandum in Form 18 in an outer cover addressed to the Government Analyst. A copy of memorandum and a specimen impression of seal is sent separately to the Government Analyst by registered post.

In case of raid or seizure of medicine at manufacturing unit, 3 seized samples are prepared following same procedure. One sample is retained by the Inspector for producing in court. The second sample is handed over to manufacturer and 3^rd sample is sent for analysis to Government Analyst.

After receipt of report of analysis, action is taken accordingly. If the report is satisfactory, regular sale is allowed. If it is not satisfactory, further legal action is taken up.

Any physical assault or a threat in writing or on telephone to Inspector while, he is discharging his duties is considered as an offence punishable with imprisonment upto 3 years or fine or both.

Forms

Form 15 - It is an order given by Inspector requiring a person not to dispose of any stock in his possession.

Form 16 - It is the receipt the Inspector tenders for the seized material.

Form 17 - It is the intimation to the person from whom sample is taken.

Form 17-A - It is receipts of samples of drugs/cosmetics taken where fair price is tendered.

Form 18 - It is the memorandum to be sent by Drug Inspector to Government analyst for the purpose of analysis of seized formulation.