“Method of investigation of NSQ and spurious drugs”�at NIHFW, Delhi�12^th June. 2024��

K. R. Chawla

Controlling Authority/Head of the Office

Drugs Control Department

Govt. of N.C.T. of Delhi

91-9811262327

• Definitions
• Method of Investigation
• Case Laws
• Case Studies
• Involving original manufacturer
• Involving others

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SCHEME OF PRESENTATION

Under section 3 (b) of “Drugs and Cosmetics Act, 1940 ” drugs are defined as -

• all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
• such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

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Drug

(iii) all substances intended for use as components of a drug including empty gelatin capsules;

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

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Drug

Cosmetic

Under section 3 (aaa) of “Drugs and Cosmetic Act, 1940 ” Cosmetics are defined as -

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“cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic

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WHY IT IS IMPORTANT TO KNOW�� SCOPE OF ABOVE DEFINITIONS

DEFINITIONS

• Misbranded drugs ---------------------------- Sec 9 & 17

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• Adulterated drugs ------------------------- Sec 9A & 17A

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• Spurious drugs ----------------------------- Sec 9B & 17B

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• Standards of quality --------- Sec 8 (1)(a) & 16 (1)(a)

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• Misbranded Cosmetics ------------------ Sec 9C & 17C

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• Adulterated Cosmetics ------------------------------- 17E

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• Spurious Cosmetics --------------------- Sec 9D & 17D

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• Standards of quality --------- Sec 8 (1)(b) & 16 (1)(b)

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• Not of Standards Quality
• Misbranded
• Adulterated
• Spurious

• Coloured, coated, powdered or polished to conceal damage
• Not properly labelled
• False claim

• Contains filthy, putrid or decomposed substance
• Insanitary conditions
• Contents injurious to health
• Colour other than prescribed
• Mixed with substance to reduce quality or strength

• Manufactured under different name
• Imitation of other drug
• Lack of identity
• Fictitious manufacturer
• Substituted by another drug or substance

Not of Standard Quality (NSQ) Drugs/Cosmetics

Drugs not complying the requirements of Section 8 of Chapter III & Section 16 of Chapter IV of Drugs & Cosmetics Act, 1940 are referred as Not of Standard Quality (NSQ) Drugs/Cosmetics.

As per Section 17 of Drugs and Cosmetics Act, 1940, a drug shall be deemed to be misbranded:

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

Misbranded Drugs

*17 (b) – Drugs which does not comply the Labeling requirements given in Drugs & Cosmetics Rules, 1945 (Rule 96 to Rule 104)

*17 (c) - Drugs which does not comply the Rule 106 of Drugs & Cosmetics Rules, 1945.

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As per Section 17 A of Drugs and Cosmetics Act, 1940, a drug shall be deemed to be adulterated:

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for the purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

Adulterated Drugs

As per Section 17B of Drugs and Cosmetics Act, 1940, a drug shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug ; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug , which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

Spurious drugs

The Indian Penal Code, 1860

• Section 274. Adulteration of drugs
• Section 275. Sale of adulterated drugs
• Section 276. Sale of drug as a different drug or preparation
• In all the above cases, IPC has prescribed imprisonment for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.

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Points of investigation

• Whether any complaint ?
• Check the elements of complaint.
• Decide about the points to be investigated.
• Contravention likely to be observed.
• Documents to be collected to prove the contraventions .
• Statement of the accused to be taken voluntarily.

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Documents to be collected where the Investigation is likely to result in prosecution

• Person in charge and responsible for the conduct of business.(Section 34)
• ID proof.
• Proof of ownership / possession (house tax receipt, electricity bill, water charges bill, property papers etc)
• If rented , rent receipt , rent agreement etc.
• Constitution of the firm.
• Statement of the accused / person involved.
• Statement of landlord.
• Spot Memo duly signed by accused and witness.

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Elements of Spot Memo

• Time of beginning, Time of completion
• Purpose of visit
• Layout plan of site/ site map indicating landmarks.
• Personal Search offer
• Public witness.
• Item wise Details of drugs/cosmetics/documents seized if any.
• Reference of sampled drugs.
• Reference of specimen samples taken.

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Elements of Spot Memo-cont

• Details of proceedings
• Reference to any disclosure sought u/s 18A/18B/22CCA etc.
• Contravention made out.
• Signature of IO, witnesses and accused.
• Acknowledgement of spot memo by the accused.
• Photographs & Videography of site, seized property, accused, witnesses etc.

Further investigations

1. On receipt of report of govt analyst.
2. Disposal of sample and test reports as per prescribed procedure.

CASE Laws

• Amery Pharmaceuticals v/s State of Rajasthan, SC (2001)
• Medicament Biotech v/s Rubina bose; SC (2008)
• Laborate Pharmaceuticals India Ltd v/s State of Tamilnadu; SC (2017)
• Varun Kapoor and Others v/s DI, Amritsar Punjab and Haryana High Court (2023)

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CASE STUDY

CASE- I , III & IV

When the Drug under reference is not manufactured by its original manufacturer.

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CASE- II

When the Drug is manufactured by original manufacturer.

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CASE STUDY- I

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Chymoral Forte Tablets

(Trypsin-Chymotrypsin Tablets)

Manufactured by

M/s Elder Pharmaceuticals, Navi Mumbai.

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�����SEQUENCE OF EVENTS

• Complaint received from the Delhi office of manufacturer M/s Elder Pharmaceuticals Ltd.,

Navi Mumbai

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• Some Chemist shops were named in the � complaint who were allegedly dealing in

spurious Chymoral forte tabs........ � Also enclosed bill of chemist.

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• Chymoral forte tablet is an enzymatic product containing Trypsin- Chymotrypsin.

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� SEQUENCE OF EVENTS � Contd. ……….

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• Premises of chemist/ retailer raided alongwith company’s representatives

(Team of two DI’s deputed)

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• Despite best efforts drugs could not be recovered initially

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• Reported to office about no recovery.

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• Took sample of other drugs stocked in the premises.

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� SEQUENCE OF EVENTS � Contd. ……….

• Suddenly one black pouch was detected in a

drawer which on opening was found

containing:

• 3x1x20 tablets of Chymoral Forte.

(Total 60 Tabs.)

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• 4x1x10 tablets – drawn as Sample u/s S-23

(Total 40 Tablets)

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• 1x20 Tablets – Specimen sample U/s 22(1)(d)

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• Spot memo prepared, witness and accused signed.

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SPECIMAN SAMPLE

� SEQUENCE OF EVENTS � Contd. ……….

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• Statement taken

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• Specimen sample sealed and signed.

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• No Purchase bill was produced on demand

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• Memo U/s 18A & Rule 65(6) issued

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• Sample forwarded to GA, CIPL, Ghaziabad.

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� SEQUENCE OF EVENTS � Contd. ……….

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Declared NSQ

&

Spurious by

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the Government Analyst

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� SEQUENCE OF EVENTS � Contd. ……….

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• Enquiry made from the Delhi office of Manufacturer
• Preliminary study pointed out the drug to be spurious.
• Directed to make final enquiry at Manufacturer’s level at Navi Mumbai.
• Spot memo after confronting the spurious sample
• Statement

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Enquiry at manufacturer level�

• Joined local DI from FDA Maharashtra.

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• On enquiry with Mfr., QA manager: Ms. Usha T

Narker was deputed.

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• Confronted the spurious sample collected for drug verification………

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• Took out 3 tablets…. Physical Comparison

Chemical Comparison (Manner of taking tablets out of strip is important)

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SPECIMAN SAMPLE

Enquiry at manufacturer level

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• Letter/Statement collected.

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• Testing in front of Investigating team

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• Reported as spurious

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• Letter from manufacturer giving the points of differences.

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• Spot Memo prepared.

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• Collected back the unconsumed portion of the � spurious sample

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FILED COMPLAINT

�� COURT PROCEEDINGS �

• Cognizance of offence
• Summoming of the accused
• Apperance of the accused/acceptence of

Bail Bond

• Handing over the copies of the complaint
• Precharge evidence
• Chief
• Cross
• Two witnesses examined…………

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�� COURT PROCEEDINGS � Contd……..

• Specimen Sample exhibited with details of investigation, documents and GA Reports.
• Framing of charges.
• Pleaded Guilty.
• Young age.
• Probation with one year community service.

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CASE STUDY - II

• ETHICON DIVISION (JOHNSON & JOHNSON) AURANGABAD
• SAMPLE OF A SUTURE(“VICRYL’ Absorbable Surgical Suture U.S.P) COLLECTED FROM UNLICENSED PREMISES REPORTED AS NSQ BY GOVT. ANALYST
• THE ACCUSED COULD NOT PRODUCE PURCHASE BILL
• SPECIMEN SAMPLE ALSO TAKEN
• ON RECEIPT OF REPORT OF GA(SAMPLE FAILED IN RESPECT OF DIAMETER), MATTER REFERRED TO STATE DRUGS CONTROLLER
• REPORT OF GA CHALLENGED BY MANUFACTURER.

CASE STUDY� Contd……..

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• CDL, KOLKATA ALSO DECLARED IT AS NSQ

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• SPECIMEN SAMPLE SENT FOR VERIFICATION TO ORIGINAL MFR.

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• MFR. CONFIRMED ITS GENUINNESS

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• PROSECUTION LAUNCHED AGAINST THE ACCUSED NO. 1 (WITHOUT LICENSE/NSQ/18 A)

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• PROSECUTION LAUNCHED AGAINST THE MFR. (NSQ)

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CASE STUDY - III

PAN D

(Pantoprazole Enteric Coated 40 mg and Domperidone Sustained Release 30 mg Capsules)

Labelled as Manufactured By –

M/s ALKEM LABORATORIES LTD., Central Pendam Block, Dugailaka, Kumrek, Rangpo, East Sikkim-737132

Contd.

• On 16/03/2018, specimen sample were taken/ collected from accused from the unlicensed manufacturing premises situated Village Kirari, Delhi
• Further, to verify genuineness of the drugs from original manufacturing firm, M/s ALKEM LABORATORIES LTD. East Sikkim
• Portion of specimen sample handed over after desealing it
• Physical & Chemical comparison were carried out by QA Deptt.
• The remaining untested specimen sample resealed
• Other necessary documents collected, spot memo prepared

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Conclusion

CASE STUDY- IV

Pantoprazole tablets IP

(Pantocid Tablets)

&

Enteric coated Pantoprazole Sodium and sustained Release Domperidone Capsules

(Pantocid DSR capsules)

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Labelled as Manufactured By –

M/s Sun Pharma Laboratories Ltd. Plot No. 107-108, Namli Block. P.O. Ranipool, East Sikkim - 737135.

�����SEQUENCE OF EVENTS

• That on 06.07.2017, the Premises of chemist/

Wholesaler raided During Special Inspection

Programme.

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• The Firm was found stocking for sale and distribution

of various drugs. On demand, firm failed to produce

the purchase records of the few drugs found stocked

in his premises on the spot at the time of inspection.

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• Legal & Specimen samples of 03 drugs were taken to

verify its genuineness from their original manufacturer.

� SEQUENCE OF EVENTS � Contd. ……….

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• Statement taken

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• Legal & Specimen sample sealed and signed.

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• No Purchase bill on demand was produced

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• Memo U/s 18A & Rule 65(6) issued

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• Sample forwarded to GA, RDTL, Chandigarh

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� SEQUENCE OF EVENTS � Contd. ……….

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Declared Spurious by

Original Manufacturer under Section 17B (e)

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Enquiry at manufacturer level�

• Joined local DI from FDA, Govt of Sikkim.

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• On enquiry with Mfr., QA manager: Sh. Prakash Singh, Deputy General Manager was deputed.

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• Confronted the spurious sample collected for drug verification………
• Took out 06 Capsules & 05 tablets…. Physical Comparison

Chemical Comparison (Manner of taking Capsules/tablets out of strip is important)

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Enquiry at manufacturer level

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• Letter/Statement collected.

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• Testing in front of Investigating team

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• Reported as spurious

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• Letter from manufacturer giving the points of differences.

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• Spot Memo prepared.

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• Collected back the unconsumed portion of the � spurious sample

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� SEQUENCE OF EVENTS � Contd. ……….

Declared NSQ by

Government

Analyst

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FILED COMPLAINT

�IN SHORT�Investigation at manufacturer level

• Confront with the specimen samples/ legal samples.
• Collect GPA/Authorization in favor of person representing the manufacturer.
• Take his ID.
• Check BPR/BMR and the supporting documents.
• Constitution of the firm as on the date of offence.
• Liability / personnel responsible for commission of offence.
• Spot memo
• Statement - Physical & Chemical Comparison
• Collect remaining portion of the specimen sample left over of the testing after sealing it properly to be exhibited in the court at appropriate stage.

QUESTIONS ?

THANKS

K. R. Chawla

Controlling Authority /Head of the Office

Drugs Control Department

Govt. of N.C.T. of Delhi

91-9811262327

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