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REGISTERED No. D. (D.N.)-72

The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub section (i)

PUBLISHED BY AUTHORITY

No. 309] NEW DELHI, TUESDAY, AUGUST 7, 1984/SRAVANA 16, 1906

Separate Paging is given to this Part in order that it may be filed as a separate compilation

(1)

619 GI/84-1

conferred by rfec.tlpni'12 and 33 of tho Drug* and Cosmetics Act, 1940 (23 of 1940), is hereby published as required By the said sections for the information of all penons likely to be affected thereby and notice is hereby eiven that the said draft rules will be taken into consideration after the expiry of a period of ninety days from the dato on which the copies of the Official Gazette in which this notification k published fire made available to the public.

Any abjection or suggestions which may oe received fjom any person with respect to the said draft rules before the expiry of the period so specified will be taken into considera- tion by the Central Government.

DRAFT RULES

1. Thesft rules may be called the Drug? end Cosmetics

(Amendment) Rules, 1984,

2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), for rule 69-A the following rule shall he substituted, namely -—

"69-A. Application for loan licences for drugs other than those specified in Schedule C, C(l) and X.—(1) Applications for the grant or renewal of a loan licence for the manufac- tures for sale of drugs other than those specified in Schedules C, C(l) and X, shall be made in Form 24A, to the licensing authority and shall be accompanied by a fee of rupees two hundred :

Provided that if an applicant applies under this sub-rule for the renewal of a loan licence after its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be rupees two hundred plus an additional fee at the rate of rupees wventy-five per month or part thereof.

(2) The licensing authority shall, before the grant of a loan licence in Form 25A, safsfy himself that the manufacturing unit of the Hcencee in Form 25 has adequate equipment, staff, capacity to manufacture, facilities for testing, and is in a posi- tion to undertake the manufacture on behalf of the appli- cant for a loan licence.

Explanation.—A licensee in Form 25 shall be deemed to be in a position to undertake the manufacture on behalf of a loan licensee, if his manufacturing unit having reserved 25 per cent of the total installed capacity or his own produc- tion, is in a position to reserve 15 per cent thereof, for the use of a loan licensee, on the basis of working single shift.

(3) For the purpose of giving effect to the provisions of sub-rule (2), the licensing authority shall have regard to the following before a licence in Form 25A is granted, namely:—•

(a) The nature of products manufactured by the licensee in Form 25 and proposed to be manufactured by the applicant.

(b) The past performance of the licensee in Form 25 in respect of products propose i to be manufactured by the applicant.

(4) No loan licence in Form 25 A shall bs granted to an

applicant on more than one licensee in Form 25.

(5) Not more than six applicants shall be granted loan

licence in Form 25A with a single licensee in Form 25.

(6) Not more than ten items per applicant shall be allowed

to be manufactured against a loan licence in Form 25A.

(7) No loan licence shall be granted in Form 25A or renewed in Form 26A for manufacture of the following cate- gories of drugs and preparations thereof, namely :

(i) Cardiac glycosides;

(ji) Ecbolic drugs;

MINISTRY OF HEALTH AND FAMILY WELFARE

(Hi) Medicinal eases:

New Delhi, the 7th August, 1984

(iv) Drugs covered under sub-clause (ii) of clause (hi of

section 3 of the Act;

(V) Bulk drugs;

G.S.R, 592.—The following draft.of certain rules further to amend the Drugs and Cosmetics Rules, 1945 which the Central Government propose to make, after consultation with the Drugs Technical Advisory Board, in exercise of the cowers

(vi) Surgical dressings, bandages and ligatures.

(8) No loan licence in Form 25A ihttlj bo granted to an

apjplkant unle"s tlie licensee in P om ZS hts—

(a) at Jcast two years experience In the manufacture of drugs to be manufactured by the loan licensee to the satisfaction if the licensing authority; and

(b) his own facilities for testing of drugs or preparations thereof to bo manufactured on behalf of the loan licensee :

Provided that the licensing authority may permit carrying out of tests involving sophisticated or specialised instruments such as infrared or gas chromatography, etc., at a testing ins- titution approved under rule 150-H.

(9) No loan licence shall be granted in Form 25A for carry- ing out a part process including labelling activities except in cases involving special manufacturing techniques such as manufacturer of soft gelation capsules, sterilisation by indi- cation and lyophifiration.

(10) A loan licence to manufacture drugs and preparations thereof shall not be granted in Form 25A to an applicant who has his own facilities 'to manufacture drugs and holds a licence to manufacture such drugs :

Provided that if the licensing authority is satisfied that for some reason the applicant is unable to utilise his own manu- facturing facilities or that the grant of loan licence is neces- sary to such applicant to meet export orders or to meet ' ^npljes to Government and serai-Government institutions, he u. y grant a loan licence in Form 25A :

Provided further that a loan licence granted under the pre- ceding proviso shall cease to be valid immediately after the exigencies for which such a licence was granted are over, notwithsatndins anything contained elsewhere in these rules.

(U) An application for manufacture of additional items on a loan licence in Form 24A shall be accompanied by a fee of rupees lifty for each item.

(12) If the licensing authority is satisfied that a loan licence in Form 25A is defaced, damaged or lost or otherwise ren- dered useless, he may, on payment of a fee of rupees one hundred, issue a duplicate copy of the said licence,

(13) No loan licence shall be granted in Form 25A or re- newed in Form 26A for the manufacture for sale of druns to—

(i) any applicant havina a direct foreign investment of

more than forty per cent:

(ii) any applicant who intends to avail himself of the manufacturinK facilities of a licensee in Form 28, having a direct foreign investment of more than forty per cent; or

(iii) any applicant who is required to but does not hold a alid licence under the Industries (Development and Regulation) Act, 1951 (65 of 1951), for manu- facture of the drucs included in the application :

Provided th&t where a company havinc a direct foreicn investment of more than forty per cent, has been cranted a loan licence in Form 25A before the commencement of ihe Drugs and Cosmetics ( Amendment) Rules, 19S4, such licence may be refused to be renewed in Form 26A beyond a date to be specified bv the Central Government in this behalf by notification in the Official Gazette.

Explanation.—For the purpose of this rule a "loan licence" means a licence wh;ch a licensing authority mav issue to an applicant, who does not have his own arrangements for manufacture but who intends to avail himself of the manu- facturing facilities owned by a licensee in Form 25, and has a valid licence for sale of drugs by WBV of wholesale in the State concerned."

3. For rule 73-AA of the sa;d rules, the following rule

shall be substiuted, namely :—

"73-AA. Duration of loan licence.—An oneinal loan licence In Form 25-A or a renewed loan licence in Form 26-A, unless sooner suspended or cancelled, shall be valid upto the 31st December of the year following the year in which it is granted or renewed or where a date of expiry has been specified in the licence, on the expiry of such, date:

Piovided that if the application for renewal of a licence is made before its expiry or if the application is made within six months of its expiry, after payment of the additional fee. the licence shall continue to be in force until orders are passed on the application :

4. For rule 74B of the said rules the following rule shall

be substituted, namely :—

"74-B. Conditions of licence in Form 25-A.—(1) Notwith- standing anything contained in rule 85, the licence in Foim 25-A shall be deemed to be cancelled or suspended. If the licence owned by the licensee in, Form 25, whose manufactur- ing facilities have been availed of by the loan licensee is cancelled or suspended, as the case may be, under these rules.

(2) The loan licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Capter IV of the Act:

Provided that where further requirements are specified in the rules, the said rules shall come into force four months after their final publication in the Official Gazette.

(3) The licensee in Form 25 shall test each batch or lot of the raw material used by him for the manufacture of pro- ducts and also each batch of the final product and shall maintain records or register showing the particulars in res- pect of such test as specified in Schedule U.

(4) The licensee shall retain the records or register refer- red to in sub-rule (3) for a period of five years from the date of manufacture and allow an Inspector to inspect all such registers and records and also supply to him such information as he- may require for the purpose of ascertaining whether the provisions of the Act and these rules have been, complied with.

(5) The loan licensee and the licensee in Form 25 shall maintain refernnce samples from each batch of the drugs manufactured by them in a quantity which is at least twice the quantity of the drugs required to conduct all the tests performed on the batch and ^hall maintain such samples.—•

(a) Where the drugs bear an expiry of potency date on the label, for a period of three months beyond the date of guch expiry, and

(b) where no such date of expiry of potency is specified, for a period of three years from the date of manufacture.

(6) The loan licensee Shall appoint at least one full time person, who holds a degree In Pharmacy or Phaimaceutical Chemistry or a full time person who holds a degree in Science with Chemistry or Microbiology as one of the sub- iects and having at least one year's experience in the manu- facture of drugs.

(7) A person referred to in sub-rule (6) shall supervise the manufacture of drugs on behalf of the loan licensee and the Iicencee in Form 25 shall permit such supervision in addition to his own staff, whenever drugs are manufactured on behalf of the lonn licensee.

(8) The loan licensee as well as the licensee in Form 15

shall be responsible for—i

(a) the qual'ty of drugs manufactured on behalf of

the loan licensee;

(b) the maintenance of records in respect of drugs pur-

chased or received on behalf of the loan Tcensee.

(9) The loan license* shall maintain records pertaining to procurement of raw materials and sales of finished products,

(10) Provisions of Part VII shall, as far as may be, apply to loan l:cence, and shall be complied with by the Iicencee in Form 25.

5. For rule 75-A of the said rules, the following rule

shall be substituted, namely :—

"75-A. Application for loan licence for Schedule C and C(l) drugs.—(1) Application for the grant or renewal of a loan licence for the manuiacture for sale of drugs specified in Schedule C and C(l), excluding those specified in Schedule X, shall be made in Form 27-A to trie licensing authority and shall be accompanied by a fee of rupees six hundred :

Provided that if an applicant applies under this sub-rule for the renewal of a loan licence atter its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be -rupees six hundred plus an additional fee at the rate of rupees two hundred per month or a part thereof.

(2) The licensing authority "hali, before the grant of a loan licence in Form 28A, satisfy himself that the manufacturing unit of licensee in Form 28 has adequate equipment, staff, capacity to manufacture, facilities for testing, and is in a position to undertake the manufacture on behalf of the applicant for a loan licence.

Explanation.—A licensee in Form 28 shall be deemed to be in a position to undertake the manufacture on behalf of a loan licensee, if his manufacturing unit, having reserved 25 per cent of the total insalled capacity for his own pro- duction, is in a position to reserve 75 per cent thereof, for the use of a loan licensee on she basis of working single shift.

(3) For the purpose of giving effect to the provision of sub-rule (2), the licensing authority shall have regard to 4he following before a licence in Form 28-A is granted, namely :—

(a) The nature of products manufactured by the licensee in Form 28 and proposed to be manufactured by' the applicant.

(b) The past performance of the licensee in Form 28 in respect of products proposed to be manufactured by the applicant.

(4) No loan licence in Form 28A shall be granted to any

applicant on more than one licensee in Form 28.

(5) Not more than six applicants shall be granted loan

licence in Form 28A with a single licensee in Form 28.

(6) Not more than ten, items per applicant shall be allowed

to be manufactured against a loan licence in Form 28A.

(7) No loan licence shall be granted in Form 28-A or renewed in Form 26A for manufacture of ths following cate- gories of drugs and preparations thereof,* namely :—

(i) Cardiac glycosides ;

(ii) Fxbolic drugs ;

(iii) Drugs covered under sub-clause (ii) of clause (b) of

section 3 of the Act;

(iv) Bulk drugs ;

(v) Surgical dressings and ligatures ; (vi) i;'l r.prenteral preparations including water for injec-

tion ;

(Vii) Human blood ;

(viii) Blood products ;

(ix) Vao.-irif.i, t.ers Q~ diagnostic reagents.

(8) No Joan licence in Form 28A

applicant unless the l'censee in Form 28 has,—

(a) at least two years" experience in the manufacture of' d vgs -p l?_ nan'rn tm.-d i-y th- '-Tin J'censee to tlv "ViK^-c'Vu of Va2 'i-: vr ",:% authority; rjr.1

(b) his own fa?;lt1ies for testing of dn.\

loan l'censee:

Provided that the licensing authority, mav -permit carrying out tests involving sophisticated or specialised instrument's 619GT/M -I

such as infra-red or gas chromatography, etc., at testing ins- titution approved under rule 150H.

(9) No loan licence shall be granted in Form 28A for carrying out a part process including labelling activities ex- cept in cases involving special manufacturing techniques such as manufacture of soft gelation, capsules, sterilisation by irradiation and lyophylization.

(10) A loan licence to manufacture drugs and preparations thereof shall not be granted in Form 28A to an applicant who has his own facilities to manufacture drugs and holds a licence to manufacture such drugs :

Provided that if the licensing authority is satisfied that for some reason the applicant is unable to utilise his own manufacturing facilities or that the grant of loan licence is necessary to such applicant to meet export orders or to meet supplies to Government and semi-Government institu- tions, he may grant a lone licence in Form 28A :

Provided further that a loan licence granted under the preceding proviso shall cease to be valid immediately aftet the exigencies for which such a licence was granted are over, notwithstanding anything contained elsewhere in these rules,

(11) An application for manufacture* of additional items on a loan licence in Form 27A shall be accompanied by a fee of rupees fifty for each item.

(12) If the licensing authority is sat;sfied that a loan licence in Form 28A is defaced, damaged, lost or otherwise rendered useless, he may, on payment of a fee of rupees one hundred, issue a duplicate copy of the said licence.

(13) No loan licence shall be granted in Form 28A or renewed in Form 26A for the manufacture for sale of drugs to:—

(i) any applicant having a direct foreign investment of

more than forty per cent;

(ii) any applicant who intends to avail himself of "the manufacturing facilities of a licensee in Form 28, having a direct foreign investment of more than forty per cent; or

(iii) any applicant who is required to but does not hold a alid licence under the Industries (Development and Regulation) Act, 1951 '65 of 1951,), for manu-

facture of the drugs :ncluded in the application :

Provided that where a company, having a direct foreign investment of more than forty per cent, has been granted a loan licence in Forms 28A before the commencement of the Drugs and Cosmetics ( Amendment) Rules, 1984 s'.xh Icence may be refused to be renewed in Form 26A beyond a date to be specified by the Central Govern- ment in this behalf by notification in the Official Gazette.

Explanation.—For the purpose of this rule a "loan licence'¹ means a licence which a licens;n_e; authority may issue to an applicant, who does not have Irs own arrangements for manufacture but who intends to avail himself of the manu- facturing unit owned by a licensee in Form 28. and has a valid licence for sale of drugs by way of wholesale in the State concerned.

6. For rule 78-A of the said rules, the fj-Howing rule shall

by substituted, namely :—•

"78-A. Conditions of licence in Form 28-A— (31 Nofwith- siandiri? nnvthine contained in n:'s 85, (he Vcr-ncs in Form 2P-A shal! be dce-ned to be canc'Vd or suspended, if the licence own"'l by "be Fcer-sec- in Form 28. whose manu- facturing facilities have been av?'>d of bv the loan lic-nnee, is cancelled or suspended, as the case may be, und"r -these rules.

*>

(2) The loan licensee hall comply w'Jh th" provision ol

_ Provided that where further requirements are specified ,p >l-pf. ...,u, *},, ep:ri ,„,,., sf]?Ij r o |w ;n^ )V>_^ f^^ months after their final publication in the Official GazeVe

(3) The licensee in Form 28 shall test each, batch or Jot of the raw material used by him for the manufacture of products and also each batch of the. Ima] product and shall maintain records or regster showing the particulars in res- pect of such test as specified in Schedule U.

(4) The licensee shall retain the records Dr registers re- fened to in sub-rule (3). tie case of a substance for which a potency date is fixed, for a period of two years from the expiry of such date, and in the case of other dubstan^e, for a period of five years from the dale of manufacture, and Allow an Inspector to inspect all such registers and records ind also supply of him such information as he may requjrc- Joi the purpose of ascertaining whother the provisions of the Act and these rules have been compiled with.

(5) The licensee shall furnish to the licensing authority, if •ecruired to do so, data on the stability of drugs which are likely to deterioate for fixing the date of expiry which would be printed on the lables of such drugs on the basis of the data so furnished.

(6) The loan licensee and the licesee in Form 28 shall

maintain reference samples from each, batch of the drugs manufactured by them m a quantity which -s at least twice the quantity of the drugs required to connduct all the tests perfoimed on the batch and maintain such samples,—

(a) where drugs bear an expiry of potency date on the lable, for a period of these months beyond the date of such expiry;

(b) where no such date of expiry of potency is specified, for a period of thn:e years from the date of manu- facture.

(7) The loan licensee shall appoint at least ene full time person who holds a degree in Pharmacy or Pharmaceutical Chemistry or a person who holds a degree in Science with Chemistry or Microbiology as one o[ the subjects and having at least one year's experience in manufacture of drugs.

(8) A person referred to in sub-rule (7) shall supervise Ihc manufacture of drugs oi behalf of the loan licensee and the licensee in Form 28 shall permit such supervision in addition to his own staff, whenever drugs are manufactured on behalf of the loan licensee.

(9) The loan licensee as well as the licensee in Form 28

Bhall be respons'bJc for,—

(a) the quality of drugs manufactured on behalf of the

loan licensee ;

(b) the maintenance of records in respect of drugs pur- chased or received on behalf of the loan Kcensce.

(10) The loan licensee shall maintain records nertaining to procurement of raw maferials and sales of finished products.

(11) Provisions of Part VII shall, as for as may be apply to loan licencee, and shall be complied with 1^y the licensee undertaking manufacture on behalf of loan licensee 7. For rule 83AA of the said rules, the following shall bo

s L.bs tiu ted, namely :-—

''83AA. Duration of loan licence.—An original loan licence in Form 28-A or a renewed loan licence in Form 26-A, unless §ooncr suspended or cancelled, shall be valid upto the 31st December of the year following the year in which it is granted or renewed or where a date of expiry has been specified in the licence, on the expiry of such date :

Provisided that if the application for the renewal of a. licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall contnuc to be in force until orders are passed on the application,:

Provided further that no loan licence shall be renewed

in Form 26A for more than two terms."

Note.—The Drugs and Cosmetics Rules, 1945, as amended upto 1-5-1979, is contained in the publication of the Ministry of Health and Family Welfare (Depart- ment of Health) containing the Drugs and Cosme- tics Act and the Rules (PDGHS-61). Subsequently the said rules have been amended by the following notifications publ shed in Part II, section 3(i) of the Gazette of India, namely:—

1. 2,

G.S.R. 1241 dated 6-10-79. G.S.R. 1242 dated 6-10-79.

3. G.S.R. 1243 dated 6 10-79.

4. G.S.R. 1281 dated 12-10-79.

5. G.S.R. 430 dated 19-4-80.

6. G.S.R. 779 dated 26-7-80.

7. G.S.R. 54O(E) dated 22-9-80.

8. G.S.R. 680(E) dated 5-12-80.

9. G.S.R. 681(E) dated 5-12-80.

10, G.S.R. 682(E) dated 5-12-80.

11. G.S.R. 27(E) dated 17-1-81.

12. G.S.R. 478(E) dated 6-8-81.

13. G.S.R. 62(E) dated 13-2-82.

14. G.S.R. 462(E) dated 22-6-82.

15. G.S.R. 510(E) dated 26-7-82.

16. G.S.R. 13(E) dated M-83.

17. G.S.R, 315(E) dated 1-5-^4.

18. G.S.R. 331 (E) dated 8-5-8-1.

19. G.S.R. 46O(E) dated 20-6-84.

20. G.S.R. 487(E) dated 2-7-84.

[No. X-1103/4/79-DMS&PFA]

S. V. SUBRAMANIYAN, Jt. Secy.

PRINTED BY THE MANAGER, GOVT. OF INDIA PRESS, R INO ROAD, NFW DELHI-1 W 0 S4

AND PUBLISHED BY THE CONTROLLER OF PUBLICATIONS, DHLHI-110054, 1 9 84