Any institution aggrieved by any decision or order passed by the Drugs Controller relating to recognition, revocation of recognition of any institution or estimates may, appeal to the Secretary to Government, Health and Family Welfare Department within ninety days from the date of receipt of the communication of such decision or order.
/pto for PPENDIX/ -16- APPENDIX FORM – ND /Al-1 (See Rules 26 and 31) …..
Here affix court fee Label to the value of Rs.2/- APPLICATION FOR THE ISSUE / RENEWAL OF A PERMIT TO POSSESS OPIUM FOR PERSONAL CONSUMPTION ON GROUNDS OF HEALTH.
To The Collector of ………………..
1 Name of the applicant (in Block letters) : Thiru/Tmt./selvi
2.
Permanent address :
3.
Address to which the permit is to be sent :
4.
Age of the applicant :
5.
Occupation and monthly income of the applicant :
6.
Grounds on which the permit is applied for :
7.
Financial year or period for which the permit is required :
8.
The quantity of opium required.
:
9.
Whether the application is for a new permit or for renewal :
10.
In the case of renewal the date of expiry of the existing permit :
11.
Whether the applicant is habituated to the consumption of opium on grounds of health :
I hereby declare –
(1) that my health will be seriously affected if I am not permitted to possess opium for personal consumption on grounds of health as recommended in the enclosed medical certificate.
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(2) that I am a resident of the State of Tamil Nadu.
(3) that the particulars given above are true and complete to the best of my knowledge and belief.
I hereby undertake to abide by the conditions of the permit and the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 and the rules made thereunder.
Signature of the applicant.
Place :
Date :
-18- FORM – ND /Al-2 (See RULE 22 (1)) APPLICATION FOR REGISTRATION / RENEWAL OF REGISTRATION AS A DEALER / CHEMIST IN MEDICINAL PREPARATIONS CONTAINING MANUFACTURED DRUGS.
…..
Here affix court fee Label to the value of Rs.2/- To The Collector of ……………………………..
1 Name of the applicant : Thiru Tmt.
Selvi
2.
Address of the applicant :
3.
The address of the premises in which the applicant proposes to carry on his business :
4.
The names of medicinal preparations containing manufactured drug which the applicant wishes to import, export or possess for sale.
:
5.
Qualifications of the applicant :
6.
Whether the applicant is himself a registered medical practitioner in Indian Medicine or whether he has in his employment a registered medical practitioner in Indian Medicine (the name and address of the registered medical practitioner to be given) :
7.
The number and date of diploma held by the applicant of the registered medical practitioner in his employment.
:
8.
Whether the applicant is an agent or distributor or a branch of a manufacturer of preparations in this or any other State :
9.
Whether the registration fee of Rs.5/- has been paid into the Treasury; (The Treasury receipt to be enclosed) : No. and date of receipt, Name of Treasury.
10.
-19- Financial year for which registration is required :
11.
Whether the application is for new registration or for renewal. If for renewal, the number and date of existing certificate of registration.
:
I hereby declare:–
(i) that the particulars given above are true to my knowledge and belief:
(ii) that I have not been convicted of any offence under the Narcotic Drugs and Psychotropic Substances Act, 1985, the Tamil Nadu Prohibition Act, 1937, the Medicinal and Toilet Preparations (Excise Duties) Act, 1955 or the rules made there under or of any cognizable or non-bailable offence;
(iii) that I am conversant with the provisions of the Tamil Nadu Narcotic Drugs Rules, 1985 and shall abide by the provisions thereof.
Signature of the applicant.
Place :
Date:
-20- FORM ND / RC.
(See Rules 5, 8(1) and (2), 21(1) and (2) and 22(1)) Permit for registration as a dealer / chemist in medicinal preparations containing manufactured drugs in the State of Tamil Nadu.
Thiru / Thirumathi / Selvi ……………………………….(Name) ……………………………………………………………………………………………………… ………………………….(address) carrying on business at premises No……………………………………….is / are hereby registered as a dealer / chemist in medicinal preparations containing manufactured drugs for the period from ……………………………………….. to the 31st March, 19 . He / She has paid the registration fee of Rs.1000/- (Rupees one thousand only) and his/her registration number is ………………………………… in the District of ……………………………… Seal of the Collector.
COLLECTOR:
DISTRICT:
To Thiru / Thirumathi / Selvi Copy to the Superintendent of Police / The Commissioner of Police.
-21- CONDITIONS I. This permit–holder shall be bound by the provisions of the Narcotics Drugs and Psychotropic Substances Act, 1985, and the Tamil Nadu Narcotics Drugs Rules, 1985 as subsequently amended from time to time.
II. This permit extends – 1) to the manufacture of manufactured drugs which the permit holder is lawfully entitled to possess;
2) to the possession and sale, otherwise then on prescription of manufactured drugs III. The permit–holder shall not have in his possession at any one time – a) opium derivatives, other than prepared opium, containing in the aggregate not more than* . . . . . . . . . . . . . . . . . . of either morphine or diacetylmorphine or both;
b) coca derivatives containing in the aggregate not more than* ..................................... of cocaine;
c) medicinal hemp upto* ............................................................ in the case of extract and * ........................................................ in the case of tincture;
d) any other narcotic substance declared to be manufactured drug upto*...................................................
He shall obtain his supplies of drugs from a licensed dealer in the State of Tamil Nadu or from a dealer licensed under the corresponding rules for the time being in force in any other part of India or by manufacture from drugs which he is lawfully entitled to possess, subject to the provisions of Condition II of this permit. The permit–holder shall not receive or have in his possession drugs otherwise obtained. He may possess opium upto* .......................................for the manufacture of medicinal opium; and shall obtain his supplies of such opium from District Treasuries only. In the case of imports of manufactured drugs from any part of India outside the State of Tamil Nadu, the permit holder shall first apply to the Commissioner of Prohibition and Excise, Madras, stating the name and address of the firm from which he wishes to purchase the drugs, the description of the drugs with their bulk weight and drug contents and obtain an import authorization before he makes intents for the drugs. If the Commissioner is satisfied that the drugs are required solely for medicinal purposes and that the permit–holder is authorized to possess the quantity of the drugs required, he will issue an import authorization.
( * to be fixed by Collectors according to requirements) -22-
Explanation: The permit-holder may obtain his supplies of manufactured drugs by import from places outside India subject to the rules published under narcotic drugs and psychotropic substances Act, 1985.
The authorization issued by the Commissioner of Prohibition and Excise, Madras, for the import of diacetyl-morphine by private persons in this State from places outside India, shall be subject to the condition that the drug shall be consigned by the exporter to the Commissioner, who shall be the authority to receive and distribute consignments of that drugs. The import authorisation issued by the Commissioner will be forwarded by him to the concerned Government department in the exporting country, with a request to issue a license to the exporting firm for the export of the drugs to the Commissioner of Prohibition and Excise, Madras. The consignment of diacetylmorphine on receipt by the Commissioner should be taken delivery of at the Commissioner’s office by the importer or will be forwarded to him at his expenses. The importer shall send his indent for diacetyl-morphine to the exporting firm direct and make his own arrangements for the payment of the cost of the drug, shipping charges, etc. to the exporter.
Solid pharmaceutical compounds (pills, tablets, etc.,) containing not more than
0.1 gramme of either codeine or dionine associated with other medicinal substances or exempt from import authorisation system and can be imported from outside India without restriction. Similarly, liquid compounds containing not more than 10 per cent of either of these substances are exempt from import authorisation system, provided such compounds do not consist of a solution of either of these substances in one or more inert fluids;
Provided that in the case of import from the United Kingdom of any preparation, admixture or other substance (except Syrupus Codeinae Phosphatis B.P.C.1934) containing any proportion of methyl-morphine (codeine) or eithyl-morphine (dionine) associated with any inert substance whether solid or liquid or any preparation, admixture or other substance containing more than 2.5 per cent of methyl-morphine or ethyl-morphine (calculated as pure drug) associated with any other medicinal substance, an import authorisation shall be obtained from the Commissioner and forwarded to the exporting firm.
IV. No consignment of manufactured drugs imported shall be opened before it has been verified and passed by an Officer of the Revenue Department not below the rank of Deputy Tahsildar.
V. The transmission of manufacture drugs by inland post by the permit-holder for medicinal purposes is permitted subject to the following conditions, namely:-
(1) only the parcel post shall be used;
(2) the parcels shall be insured;
-23-
(3) the parcels shall be covered by permits which shall in the case of transmission to a district within the State of Tamil Nadu be issued by the Collector of that district and in other cases by the proper authorities in the State to which the parcels are addressed;
(4) the parcels shall be accompanied by a declaration stating the names of the consignee and the consignor, the contents of the parcels in detail, the number and date of the permit covering the transmission and the number of the permit held by the consignee; and
(5) the consignee shall show distinctly in his account books the name of the consignor and the quantity of drugs sent to him, from time to time, by post.
VI. The permit-holder shall not manufacture, possess, or sell manufactured drugs by virtue of this permit at any place except his place of business specified above.
Manufactured drugs shall be kept in special locked receptacles, the key of which shall be in the custody only of the licensed dealer or of his qualified assistant.
VII. The permit-holder shall mark every package or bottle or bottle containing manufactured drugs with the percentage or proportion or amount of opium, cannabis, indica, morphine, Diacetyl-morphine or cocaine contained in the drugs.
VIII. (1) The permit-holder may sell, otherwise than on prescription, manufactured drugs only –- a) to another dealer or chemist permitted under the Tamil Nadu Narcotic Drugs Rules, 1985 or under the corresponding rules for the time being in force in any part of India outside the State of Tamil Nadu;
b) to a person authorised under the Tamil Nadu Narcotic Drugs Rules, 1985 or under any corresponding rules for the time being in force as aforesaid;
c) to any person authorised to export the drugs under the Tamil Nadu Narcotic Drugs Rules, 1985;
d) to the Medical Officer in charge of a Government hospital, dispensary or other Government institution on an indent counter–signed by the District Medical Officer in the case of institutions in the mofussal and by the Director of Medical Services in the case of institutions in the city of Madras:
Provided that the quantity that may be sold to the persons mentioned in clauses (a) to (c) shall not exceed the quantity which they may lawfully possess:
Provided further that the quantity of cocaine hydrochloride sold in its pure form at any one time to a chemist permitted under the Tamil Nadu Narcotic Drugs Rules, 1985 or under the corresponding rules for the time being in force in any part of India outside the State of Tamil Nadu shall not exceed 3 gms. and that to an approved practitioner shall not exceed 2 gms:
-24-
Provided also that no counter–signature shall be necessary in the case of indents from Government institutions for the supply of phethidine also known under the names of dolant in demerol not exceeding 2 gms. at any one time and that all indents from Government institutions for the supply of phethidine exceeding 2 gms. at any one time shall be counter–signed by the Director of Medical Services:
Provided also that the drugs shall not be delivered to any person, not permitted or otherwise authorised to be in possession of the drugs, who, purports to be sent by or on behalf of a person so permitted or authorised, unless an authority in writing, signed by the person so permitted or authorised to receive the drugs on his behalf is produced and unless the licensed dealer is satisfied that the authority is genuine.
(2) Such drugs shall be sold only in packages or bottles plainly marked with the amount of the drugs in each package or bottle.
(3) Any preparation, admixture, extract or other substance containing such drugs shall be sold only in package or bottles, plainly marked –-
(a) in the case of powder, solution or ointment, with the total quantity thereof in each package or bottle and the percentage of the drug in the powder, solution or ointment; and
(b) in the case of tablets or other articles, with the quantity of the drug in each article and the number of articles in each package or bottles.
(4) The permit-holder shall not be a party to the transport of any manufactured drug from one licensed dealer’s shop to another or to any licensed chemist’s shop in the State of Tamil Nadu unless it is covered by a permit issued by the Collector of the District to which the transport is made or by the licensed dealer, from whose shop the drugs are transported.
IX. The permit-holder shall, on requisition by the Commissioner or any other Officer duly authorised by him in this behalf, deliver up his permit for amendment or for the issue of a fresh licence.
X. Stocks of manufactured drugs, other than prepared opium, and all accounts and records of transactions under this permit shall be open to inspection—
(a) in the case of the permit–holder being an approved practitioner, by any officer of the Revenue Department not below the rank of a Tahsildar or by any officer of the Police Department not below the rank of an Inspector or any officer of the Drugs Control Department not below the rank of Drugs Inspector and -25-
(b) in the case of other permit-holders, by any officer of the Revenue Department not below the rank of a Deputy Tahsildar or by any officer of the Police Department not below the rank of Sub-Inspector of any officer of the Drugs Control Department not below the rank of a Drugs Inspector.
XI. The permit-holder shall be bound to purchase in such quantity, not exceeding that which he is likely to sell or use in two months as the Collector may direct, any manufacture drugs that may be delivered up to the Collector by any other permit-holder whose permit has expired or has been cancelled or suspended or otherwise.
XII. All preparations containing not more than 0.2 percent of morphine or 0.1 percent of cocaine and any preparation which the Central Government may by notification in the Gazette of India made in pursuance of a finding under Article 8 of the Geneva Convention declare not to be a manufactured drug, may be imported, exported, transported, possessed and sold without restriction.
Dated the day of 19.
Station:
Collector.
-26- FORM – ND/PP [See Rules 26(4)] No.
Taluk:
Permit for possession of Opium for personal consumption on grounds of health.
Thiru/Thirumathi./Selvi…………………............................Name……………….........
aged...........................................(Occupation), Wife/Daughter/Son of..........................
residing at ............................................. (address) is hereby permitted to possess opium for personal consumption on grounds of health from ........................................ to the 31st March 19 subject to the following conditions.
1. This privilege extends only to the possession for personal consumption of opium upto the limits prescribed in condition 2 below.
2. The quantity of opium that may be obtained under this permit shall not exceed ........... gram(s) in a month.
3. The monthly quota is subject to the reduction of ................... (gram) every month / quarter commencing from ....................
4. The opium that may be assessed under this permit shall be purchased by the permit-holder only at ............................ District Treasury and it shall not be sold or transferred to any person.
5. For obtaining opium from the District Treasury under condition 4 above, the permit-holder shall pay the issue price at the rate notified by the Commissioner and produce this permit before the District Treasury Office who shall make an endorsement in the appropriate columns, showing the quantity of opium issued, the date of issue etc.,
6. The permit-holder shall invariably carry this permit on his person when in possession of the permitted quantity of opium and shall produce it forthwith on demand by any officer competent to make such demand.
7. The permit is not transferable. Where a permit is suspended or cancelled during its currency or is not renewed after its expiry, the permit-holder shall surrender forthwith, the entire stock of unconsumed opium or opium mixture to the Tahsildar.
Signature of the literate or the left hand thumb impression of the permit-holder Two personal identification marks of the permit-holder
(1)
(2) Place:
Date :
Seal : COLLECTOR.
-27- FORM ND/ME [See Rule 28(2)] RECORD OF MEDICAL EXAMINATION 1 Full Name and Address of the examinee : Thiru./Tmt./Selvi 2 Age :
3 Sex :
4 Weight :
5 Blood Pressure :
6 (a) General Physical Condition:-
(b)1. Evidence, if any to show that the examinee is habituated to opium.
2. Evidence for loss of weight, if any.
3. Condition of heart and blood vessels.
4. Presence of any disease for which examinee is required to use or consume opium (the name of the disease with information whether it is an incurable or painful disease may be mentioned).
7 Period for which the examinee is habituated to consume opium.
:
8 Quantity of opium recommended by the Examinee’s personal medical adviser, if any, and the reason given by him for such recommendation.
:
9 Quantity of opium recommended per mensem by the Medical authority and also its reasons for recommending / refusing the use or consumption of opium by examinee.
:
Place:
Date :
Signature with the designation of the Medical Authority.
-28- FORM ND/ RG-1 (See Rule 29) - - - - - - - Register of Permits for Personal Consumption of Opium Issued for the financial year from the 1st April, 19 to the 31st March, 19 .
- - - - - - TALUK :
Sl.
No.
No. and date of the personal permit Full name and address of the permit holder.
A g e S e x O c c u p a ti o n Quota allowed per month No. and date of the Collector’s Order for issue of the permit Remarks
1. 2. 3. 4. 5. 6. 7. 8. 9.
-29- FORM ND/ RG-2 (See Rule 29) Register of Certificates of Registration issued for the financial year from the 1st April, 19 to the 31st March, 19 .
DISTRICT :
Sl.
No.
Name and Address of the Applicant registered.
No. & Date of Collector’s Proceedings.
No. & Date of Certificate Issued.
Remarks
1. 2. 3. 4. 5.
-30- FORM ND/ TP-2 [See Rule 25(1)] - - - - - - - Permit for transport of medicinal preparations containing manufactured drug from a licensed dealer to another licensed dealer.
Thiru. / Thiruvalargal / Thirumathi / Selvi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . (Name and address of the purchasing licensed dealer) is / are permitted to transport by rail / road, medicinal preparations containing manufactured drug as particularised below*.
from …………………………………………………………………. (Name and address of the supplying licensed dealer) to …………………………… (Place of business or premises authorised in the permit of the purchasing dealer). The number and date of the permit held by the purchasing dealer is . . . . . . . . . . . . . . . .
(*) Sl.
No.
Name of the medicinal preparations containing manufactured drug Quantity
2. The permit shall be valid from . . . . . . . . . . . . . . . . . . . . . . . . to . . . . . . . . . . .
. . . . . . . . . . . . . It shall be used only once during its currency and shall be carried along with the consignment.
3. The consignment shall not be broken in bulk while in transit and shall be transported in one lot.
Place:
Date :
COLLECTOR.
To Thiru. / Thiruvalargal / Thirumathi / Selvi . . . . . . . . . . . . . . . . . . . .
Copy to the Collector of -31- FORM ND/ AC-I [See Rule 10] - - - - - - - FORM OF ACCOUNTS TO BE MAINTAINED BY APPROVED PRACTITIONERS FOR MANUFACTURED DRUGS ADMINISTERED BY THEM Particulars of transactions receipts, issues, balance, etc., in each month Opium derivatives Coca derivatives Medicinal hemp. Other narcotic substances declared to be manufactured drugs Name and address of the person from whom purchased and the data purchase Extract of hemp.
Tincture of hemp.
(i) (ii)
(1) (2) (3) (4) (5) (6) D e s c ri p ti o n B u lk w e ig h t D ru g c o n te n t D e s c ri p ti o n B u lk w e ig h t D ru g c o n te n ts D e s c ri p ti o n B u lk w e ig h t D ru g c o n te n ts D e s c ri p ti o n B u lk w e ig h t D ru g c o n te n ts D e s c ri p ti o n Q u a n ti ty Stock on hand Quantity purchased in the month Total quantity expended in the month either for administration in solid form or for preparation of solutions.
Balance of Stock at the end of the month.
NOTE: Records of the transactions in this form are required to be maintained only for each month.
T.V. Venkataraman Special Commissioner & Secretary to Govt.
Section Officer.
-32- FORM ND/M1 (see rule 47) Application for grant of Recognition to Medical Institution To The Director of Drugs Control, Chennai – 600 006.
1 Name of the Institution and address 2 Name of the Head or In-charge of the Institution 3 No. of persons employed:
(i) Doctors
(ii) Nursing Staff
(iii) Others 4 No. of patients treated during the previous calendar year
(i) Inpatient
(ii) Outpatient 5 Whether the hospital has facilities to treat cancer patients Yes/No 6 No. of cancer patients treated During previous calendar year.
(i) inpatient
(ii) outpatient 7 Name of the qualified medical Practitioner who would prescribe Morphine (If there are more than one qualified medical practitioner who would prescribe morphine, indicate the name of the medical practitioner who would be overall In-charge) 8 Whether the institution’s recognition for the purpose was withdrawn earlier (if the recognition was withdrawn earlier the details are to be given) Yes/No Station: Signature of the Head/in-charge Date: of the institution with name -33- FORM ND/M2 (See rule -48) Record of receipt, disbursement and balance of Morphine:
Date:
Quantity in hand at the beginning of the day Details of quantity received Details of quantity disbursed Quantity in hand at the close of the day S.No Quantity From consignment S.No. Quantity Name of Name Whom note/bill the person of the Received of entry No. and Medical address to practitioner whom disbursed was who Prescribed Signature Note:
1. This record is to be maintained on day to day basis and entries shall be made for each day the institution functions. Entries shall be completed for each day before the close of the day. The authorized Medical practitioner/in-charge or any person authorized by them shall initial after entry of each day with date. The pages of the register shall contain necessary number.
2. This record shall be retained for two years from the date of last entry.
3. This record shall be produced to the authorized officers whenever called upon during the course of their inspection.
-34- (FORM ND/M3) (see rule-49) Estimate of annual requirement of Morphine
(1) Name and address of the recognised medical institution
(2) Period for which the estimate is submitted
(3) Quantity estimated to be disbursed during the previous year.
(4) Quantity estimated to be disbursed during the year for which estimate is submitted
(5) Supplier who would supply the quantity ------------------------------------------------------------------------------------------------------------ Sl.No. Name and address Quantity of the supplier ------------------------------------------------------------------------------------------------------------
(6) If this is supplementary requirement, give details of annual requirement sent earlier and the reasons for giving a supplementary requirement.
Station: (Signature of the Authorised Date : medical practitioner/ In-charge with name) -35- (FORM ND/M4) (see rule-52) Orders for purchase To ----------------------------------- ----------------------------------- (Name and address of the supplier) 1 Name and address of the recognised medical Institution which places the order 2 Description of the quantity for which order is placed 3 Whether the institution has been recognised by the Drugs Controller (A photocopy of the recognition is to accompany each order for purchase) 4 Whether this order is covered by the estimate approved by the Drugs Controller (A photocopy of the approved estimate is to accompany each order for purchase) 5 Details of other orders for purchase made during the year ----------------------------------------------------------------------------------------------------------- Sl.No. Quantity To whom order was placed ------------------------------------------------------------------------------------------------------------ Station: (Signature of the person authorised Date : to place order with name and Designation, if any.)
Note:-
1. A copy of this order shall be kept by the recognised medical Institution which places the order.
2. This shall be retained for two years from the date of transaction.
-36- (FORM ND/M9) (see rule-52) CONSIGNMENT NOTE To accompany a consignment of morphine Date and time of dispatch of the consignment……………….
1. Name and address of consignor
2. Name and address of the consignee (recognized medical institution)
3. Description and quantity of the consignment:
--------------------------------------------------------------------------------------------------------------------- No. of Packages Quantity Gross Net ---------------------------------------------------------------------------------------------------------------------
4. Mode of transport (Particulars of the transporter, Registration Number of the vehicles, RR, if the transport is by railways etc.)
Signature of the Consignor with date (Name and designation, if any) To be filled by consignee:-
5. Date and time of receipt by the consignee and his remarks
6. Quantity received by the consignee.
--------------------------------------------------------------------------------------------------------------------- No. of Packages Quantity Gross Net --------------------------------------------------------------------------------------------------------------------- Signature of the Consignor with date (Name and designation, if any) Note:-
1. This consignment note shall be serially numbered on annual basis.
2. The consignor should record a certificate on the cover page of each Book containing consignment notes indicating the number of pages contained in the consignment note-book.
3. The consignor should maintain a Register showing the details of the books of consignment note brought in use during the particular year.
-37-
4. Each consignment of morphine shall be accompanied by the consignment note in quintuplicate.
5. The consignment not shall be retained for a period of two years from the date of transaction.
6. The records referred to at items 2 to 5 above in this note shall be produced to the authorized officers whenever called upon during the course of their inspection.