Contents of this chapter
•Administration of the act and rules
•Provisions related to Import
•Provisions related to Manufacture
•Provisions related to Sale
•Labeling and Packaging
•Schedules to the act and rules
• At the end of this lecture, student will be able to
– Discuss the qualifications, functions and duties of Drugs Inspector
– Discuss the provisions for import of drugs under license
– Discuss the provisions for import & registration of Drug & Cosmetics
1 Persons having qualification 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, or (b) a chemical examiner, or (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.
Import Manufacturing Sales
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
For appointment as DI, person must have a degree in Pharmacy/Pharmaceutical
Chemistry/Medicine with specialization in Clinical Pharmacology/Microbiology from a
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
❑ 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
❑ 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 by means of
which the offence has been ,or is being, committed
❑ 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
❑ 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
❑ exercise such other powers as may be necessary for carrying out the purposes of the Acts or
Duties of 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
➢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.
➢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.
➢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.
➢To take samples of drugs manufactured on premises & send them for test or
➢To institute prosecutions in respect of breaches of Act and Rules.
Procedure for Drug Inspectors
➢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)
➢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
➢The sample if made into small volume is likely to deteriorate, Inspector can take three or more
containers when necessary after suitably marking it.
➢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.
➢Inspector should sent sample to Government Analyst by registered post or by hand in sealed
packet enclosed together with memorandum in Form 18 in an outer cover addressed to
Government analyst. www.DuloMix.com
➢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.
➢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.
➢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.
➢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
➢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.
➢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.
Import of Drugs
-Classes of drugs prohibited to import
-Import of drug under license
1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported for Test/Analysis
4)Imported for personal use
5)Any new drugs
-Offences and Penalties
Import & Registration of Drug & Cosmetics
-Drugs/cosmetics may be imported to India under the authority of a license excepting those
whose import is prohibited.
-Some drugs/cosmetics can be imported without any permit, providing they are of standard
quality & statement that they comply with the provisions relating to import has been given
to the Customs Collector by manufacturer or importer.
Requirement of registration of premises & drugs manufactured & meant for the import
to India was introduced with effect from 1.1.2003
– Registration Certificate means a certificate issued by the LA for the registration of premises &
drugs manufactured by the manufacturer meant for import into & use in India.
– An application for the issue of a registration certificate should be made to LA along with the
information & undertaking specified in Schedule DI & DII. Registration certificate remains valid for
a period of 3 years.
-Requirements of Schedule D I are as follows
I. Particulars of manufacturer & manufacturing premises- i) name & address of
manufacturing premises to be registered. Ii) name & address of partners/directors iii)
name & address of authorized agents in India. Iv) brief profile of manufacturer’s business
& research activity v) copy of plant master file. vi) copy of plant registration/approval
issued by authority of concerned foreign country.
2. Particulars of manufactured drugs to be registered under registration certificate- i)
name of drug to be registered for import into & use in India. ii) a copy of approval list of
above drugs showing permission for manufacturing/marketing in the country of origin.
iii) a copy of GMP certificates as per WHO guidelines. iv) domestic prices of drugs to be
imported in the currency of country of origin, v) names of drugs which are original
products of the manufacturer.
3. Undertaking to declare that- i) that applicant shall comply with the conditions
imposed under acts & rules, ii) applicant report from time to time any changes
pertaining registration certificate or any administrative action taken due to ADR, iii)
applicant shall allow LA to enter & inspect manufacturing premises & to examine
process or procedures & allow to take samples of drugs concerned for test, analysis or
examination, in respect to any drug manufactured for which application for registration
certificate has been made.
➢ Persons having qualification for appointment as government as Governmental Analysis for allopathic drugs ;
or having a degree in ayurveda, siddha or unani system and not less than three year post graduate experience in
the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examiner, or (c)
head of an institution specially approved for this purpose
➢ They can Inspect, any premises where in any drug or cosmetic is being manufactured
➢ Any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or
Import of drug under license
1)Specified in Schedule-C/C1 2)Specified in Schedule-X
3)Imported for Test/Analysis 4)Imported for personal use
5)Any new drugs