Opioid Availability for Medical Use Under the NDPS Amendment of 2015

1. Opioid Availability for Medical Use
Under the NDPS Amendment of 2015
[ GSR 359(E) issued by Ministry of Finance dated 05.05.2015 ]
Dr. E. Anandakirouchenane M.Pharm., Ph.D.,MBA(HRM)
Controlling cum Licensing Authority
Department of Drugs Control, Puducherry
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2. This Discussion Related to…..
A. Rational use of Essential Narcotics Drugs falling under the
category of NDPS Rules
B. Procedures related to Licensing Process
C. Conditions of the Licence
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3. Role of DDC in Implementing NDPS
DDC
SERVICE
* Issuing the Licence to the
Medical Colleges
/Hospitals/RMPs
(Form 20 F& 20 G)
*RMI Licence in Puducherry UT
ENFORCEMENT
* Regulating and
Monitoring the usage of the
Narcotic Drugs in UT of
Puducherry
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4. Procedures adopted in UT of Puducherry
prior to Feb-2022
Step 1: Grant of Licence in Form 20 F & 20 G
Step 2: Obtaining NOC for Required Quantities
Step 3: Transit permission from Excise Department
To avoid this time taking cumbersome process
Government of India issued the new amendment on
05.05.2015 GSR359(E), Narcotic Drugs and Psychotropic
Substance (Third Amendment) Rules, 2015.
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5. Current Scenario
oThe UT of Puducherry appointed The Licensing cum
Controlling Authority under Rule 50 of the Drugs and
Cosmetic act (23 of 1940) acts as Controller of Drugs as per
Narcotic Drugs and Psychotropic Substance (Third
Amendment) Rules, 2015.
oThe Controller of Drugs will issue the Recognized Medical
Institution Licence to simplify the process in UT of
Puducherry.
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6. Name of Essential Narcotics as per the Act
Morphine
Methyl Morphine – Codeine
Dihydroxy Codeinone - Oxy Codone
Dihydro Codeinone – Hydrocodone
N-(1-(2-phenethyl)-4-piperidinyl-N-phenyl-propanamide –
Fentanyl
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7. Eligibility Sale of Narcotic Drugs
A. A licenced Dealer ( Who holds Licence in Form 20 G)
B. A licenced Chemist ( Who holds Licence in Form 20 F)
C. A Registered Medical Practitioner (Registered under
Indian Medical Council Act, 1956/ The Dentist Act, 1948)
D. A person who has been authorized by Controllers of Drugs
(Controlling Authority) under these rules
E. A Recognized Medical Institution
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8. Procedure for obtaining Form 20
F & 20 G
oApplication in Form 19 C - Application for grant or renewal of a
licence to sell, stock, exhibit or offer for sale, or distribute of drugs
specified in Schedule X.
oApply online through xlnindia.com portal
oPay prescribed fee Rs.500/- through e-gras Puducherry
oMandatory Requirement:
• Lock & Key, Pull-in & Pull-out Register, Additional Pharmacist &
Prescription and Usage Register.
oOnce approved licence issued in Form 20 F (Retail) /Form 20 G
(Wholesale)
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9. Procedure to Obtain Licence as Recognized
Medical Institution
1
• Submit Your Application in Form 3F
2
• Enclose following Documents
• Education Qualification & Council Registration of the Medical officer
• Experience certificate of Medical officer, In charge & Pharmacist
• Copy of Form 20 G /20 F
• E-Challan Rs.3000/- ( Paid Through e-gras Puducherry Website)
• Existing Institution – last year usage details with copies of invoices
• If any change in Quantity – mention the Reason and Justification
3
• Verification of the Medical officer / In charge
4
• Issuance of licence in Form 3 G With 3 Years of Validity
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* Currently 9 institutions in Puducherry UT received Form 3G

10. Exemptions
 All Government Sector Hospitals /Medical Institutions with
at least 1 Registered Medical Practitioner possessing
minimum qualification of Degree in Medicine/Dentistry.
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14. Conditions of the Licence
oMaintain records on Form 3 D, at least for 2 years.
oSubmit Usage Details to DDC on monthly basis
oMedical practitioner shall maintain record in Form 3 E, at least for 2 years.
oFill return for a calendar year on or before 31th March of the subsequent year in
Form 3 I to the Controller of Drugs.
oEvery RMI shall submit an estimate of its annual requirements of its Drugs in
Form 3 J by 30th November.
oExpiry/Damage stocks shall be destroyed by the RMI in the presence of an Officer
nominated by the Controller of Drugs.
oUnused Drugs returned by the patients are considered as receipts by the RMI.
oDrugs shall not be Transferred/Loaned/Sold by the RMI to another Institution
without the approval of Controller of Drugs.
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16. Conditions to the Prescriptions of RMP
oPrescription shall be in the writing, dated and signed by the
practitioner with his full name, address & Registration number
oShall specify the name and address of the person to whom the
prescription is given.
oTotal quantity of the essential narcotic drug
oDaily dose, Strength & period of consumption
oThe prescription shall not be given for the prescriber itself.
oShall maintain record in Form 3 E, at least for 2 years
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19. Penalties
oAs per the Drugs and Cosmetic Act 1940 and rules made
thereunder & Narcotic Drugs and Psychotropic Substance
Rules 1985.
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E-Mail: ddc.pon@gmail.com
Phone: 0413-2353647