MINUTES OF THE FORTYFOURTH DRUGS TECHNICAL ADVISORY BOARD MEETING HELD ON JANUARY 10, 1994 AT NEW DELHI

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1 MINUTES OF THE FORTYFOURTH DRUGS TECHNICAL ADVISORY BOARD MEETING HELD ON JANUARY 10, 1994 AT NEW DELHI The Chairman, Dr. A.K. Mukerjee, DGHS, welcomed members attending the meeting. He was glad that most of the members had made it convenient to attend the meeting. He informed the Board the apologies for absence had been received from Shri A.B. Pathak, Govt. Analyst, M.P., Dr. S.C. Lahiri, ICMR, Calcutta and Sh. Devinder Pal, Indian Pharmaceutical Association, Bombay. After introduction, the Chairman informed them that consequent to the orders of Supreme Court that representations of the manufacturers concerning fixed dose combinations of Corticosteroids with other drugs should be placed before the DTAB with fresh material, if any, and Board after co-opting an expert in Asthma may dispose off the representations according to the merit. Dr. D.D.S. Kulpati, an Expert in Chest Medicine, had been co-opted for the purpose. He believed that the representations of the petitioners alongwith the Court Order, were already with the members and based on these materials and in consultation with Dr. Kulapati, the members could kindly give their opinion. The Chairman requested members to discuss, in detail, prohibiting certain combinations of drugs under Section 26A of the Drugs and Cosmetics Act. He further added that members were well aware that lot of concern had been expressed in lay press, Consumers Fora, Parliament that wide varieties of Patent and Proprietary Oral Rehydration Salts are moving in the market whose efficacy and safety are questionable. The Expert Committee had reasons to recommend streamlining formula of the ORS being marketed in the country. The Chairman invited attention of the members on the action taken on matters which were discussed in the last meeting. He requested the members to examine matters under various agenda items relating to quality, availability, laying down standards and devise ways to curb the menace of spurious and adulterated drugs. The Chairman felt that there has to be an effective mechanism of probing and investigating for which strengthening of Drugs Control Administration is necessary. The Chairman informed the members that the agenda under discussion include certain items which were discussed earlier but shall need reconsideration to finalise them. He cited examples where saving clauses shall have to be given to the RMP who are already in the profession. The Chairman requested members that while discussing saving clauses, cut off dates should be specified as far as possible in consultation with the respective Councils which may include Dental, Medical, Pharmacy. The Chairman requested members that the subcommittees, if any, constituted by the Board should submit their expert views and recommendations within stipulated period for expeditious decisions by the Board. Likewise, the members were requested to offer their comments on the specific agenda, if any referred to them as early as possible. 1

2 The Chairman categorically desired that while circulating agenda to the members, care should be taken that the reports of the Experts Committee/Sub-Committees were also invariably annexed so that the members can examine pros and cons of the matter. The Chairman also requested members that matter concerning cosmetics can be discussed with representatives of BIS who were special invitees in this meeting. The members were also informed that Central Government convened 29 th DCC meeting on 6 th & 7 th January, 1994 and had recommended certain items which would be discussed as supplementary agenda in this meeting. The members were requested to give their opinion on these matters also. The Chairman requested Member Secretary, Dr. P. DasGupta, Drugs Controller (India), to inform members on the action taken/initiated on various items which were taken up during the last meeting. The Secretary explained to the members the nature of action taken on the various points arising out of the minutes of the last meeting. ITEM NO. 1 Consideration of the minutes of the Forty Third meeting held at New Delhi on 29/3/1993. No comments were received on the minutes of the last meeting. The minutes of the last meeting of the Board were, therefore, confirmed. ITEM NO. 2 Consideration of the question arising out of the minutes of the Forty Third meeting. Secretary explained to the members the nature of action taken on the various points arising out of the minutes of the last meeting. He stated that some of the items discussed at the last meeting were coming up for consideration again as agenda items. In respect of other items, action has been initiated for publishing draft amendment, to the Drugs and Cosmetics Rules, The Chairman referred to the following items of the Statement of Enclosure-A of the Agenda and desired to know their opinion on the said items: (a) Amendment of Rule 148 concerning labeling of cosmetics with composition and date of expiry (DOE). On the request of the Secretary, BIS officials who attended the meeting explained that it is the responsibility of the manufacturer to assign the date of expiry upto which his product would remain stable. The members urged that a self-contained note on the subject should be prepared by BIS for their comments. The critical ingredients required to be given on the label of the cosmetics should also be identified. 2

3 Chairman asked BIS officials to send a detailed note on the Cosmetics included in Schedule S of Drugs and Cosmetics Rules which would then be circulated to the members for their comments. (b) Rule 2 (ee) of the Drugs and Cosmetics Rules, 1945 defines the persons who can be considered as RMP. The said rule has five clauses which give different qualifications for the said persons. Clause (iii) gives the definition of an RMP declared by a general or special order made by the State Government in this behalf as a person practicing the Modern System of Medicines for the purpose of this Act. Based on the recommendations of the 27 th DCC, DTAB in its 43 rd meeting approved the omission of the clause (iii) under the said rule. It is, however, intended that a proviso to the sub-clause may be kept for protecting such persons who may have already been authorized as RMPs under the said clause. While considering the matter, the Chairman felt that before providing a saving clause for deletion of clause (iii) of Rule 2 (ee) of the Drugs and Cosmetics Rules for RMP, the cut-off date should be confirmed from Medical Council of India before the matter is considered for publishing it as Notification. (c) Consideration of laying down minimum and maximum content of individual vitamins in respect of P & P medicines meant for use of animals in Schedule V of the Drugs and Cosmetics Rules, The Secretary explained the back ground against which the amendment of Schedule V in respect of P and P Vitamins preparations meant for use of animals was discussed by the members in the last meeting. As desired by the Board, the Secretary had sought opinion from Director, IVRI to advise whether P and P medicines containing vitamins meant for Vet. Formulations require any minimum and maximum limit for quantity of vitamins that should be incorporated in the said medicines. The members discussed the matter and recommended that before carrying out the amendments of Schedule V for stipulating minimum and maximum content of individual vitamin for veterinary preparations, DTAB may constitute a special committee to work out a draft guidelines under the Chairmanship of Director IVRI which may include Dr. B.E. Rao, Shri A.K. Das, Drugs Controller, Orissa, Govt. Analyst, Maharashtra. As advised by Dr. Rao, the committee may also co-opt representatives from National Dairy Development Board and from Veterinary Vaccine Board, Krishi Bhavan, New Delhi. The committee shall give its report within time frame of 3 months. (d) Consideration of amendment of Schedule M with regard to Large Volume Parenterals (LVPs) The Secretary brought to the notice of the members that consequent to the alleged report of adverse reaction/death on administration of LVPs (I.V. fluids), a complaint was filed by 3

4 Common Cause, New Delhi before the National Consumers Disputes Redressal Committee under the Consumers Protection Act, The Commission suggested to review the provisions of existing legislation for ensuring Quality and Safety of I.V. fluids. DTAB in its last meeting had considered the amendment of Schedule M including specific provisions for LVPs. The proposal was also agreed to by the Drugs Consultative Committee so that stringent control over premises, quality and manufacture of LVPs is ensured. While carrying out the exercise of amending the Schedule M in respect of LVPs, it was observed that the proposed legislation worked out by the Expert Committee related to LVPs in glass bottles only. The Secretary requested members to opine whether such legislations could also include components regarding Blow-Fill-Seal Technology with regard to manufacture of LVPs in Plastic containers. The Board decided that the recommendations of the earlier Expert Committee constituted by the Ministry of Health and Family Welfare for amendment of Schedule M with regard to LVPs in glass bottles will be circulated to the new subcommittee constituted as under: Dr. B.E. Rao Sh. A.G. Shah Dr. P.D. Pilankar Chairman Member Member The Chairman may co-opt any other expert for the said purpose. The subcommittee shall examine the guidelines as well as inclusion of components regarding BFS Technology with regard to Plastic Containers. The Board decided that the committee constituted should give its report within a time frame of 3 months proposing comprehensive draft legislations on the said matter under the Drugs and Cosmetics Rules, (e) Consideration of effective recall of drugs. The Secretary explained to the members that in the last meeting, the Board had discussed the modalities of procedure that may be laid down under rule 66 and rules 74 and 78 for effective recall of drugs within the shortest time period by the sale licensees as well as the manufacturers of drugs which are reported to be not of standard quality, adulterated or spurious on testing. The Secretary has received views from some of the members. The members after going through the modalities circulated again by the Secretary opined that the period of 48 hours for recall of drugs by the licensees does not seem to be practicable. After discussion, the members were of the consensus opinion that the modalities recommended by the subcommittee of DCC need further examination and as such they may be given time to send their comments. It was decided that the members would furnish their views on the modalities within one month. 4

5 In the meanwhile, the Secretary would arrange to send the modalities to the President of Indian Pharmaceutical Association, who is a member of the Board, for his comments, as the provisions of the procedure for effective recall of drugs is to be implemented by the Pharmaceutical Industry. (f) Consideration of the question of deleting Rules 116 to 119 and amendments to Rules 115, 121 and 121-A. With regard to the proposed revision of Part X of the Drugs and Cosmetics Rules, a status paper was prepared by the Directorate which has been circulated to all the members for comments for finalization before publishing draft notification. It was decided that the members shall send their comments to Director, Central Drugs Laboratory, Calcutta who will collate the comments received from the members and prepare a draft amendment to revise Part X of the Drugs and Cosmetics Rules, He would send the report to the Secretary within a period of 3 months. (g) Consideration of items requiring amendments of Drugs and Cosmetics Act, The Secretary informed the members that Ministry of Health and Family Welfare would in consultation with the Department of Legislation, Ministry of Law shall prepare a Bill for carrying out amendments to the said Act. With regard to amendment of Section 23 (2) of the Act for making necessary prescribe form, the Secretary opined that where the price tendered under sub-section (1) is refused to the items seized by the Inspector under clause (c) of Section 22, the Act lays down in the clause (i) of Section 3 that the prescribed form can be made under the Drugs and Cosmetics Rules, The Board agreed with the view and approved the proposal for making necessary provisions under the Rules. However, Commissioner, FDCA, Gujarat was requested to send a Format of the form which should be prescribed under the Rules. ITEM NO. 3 Consideration of the representations of the manufacturers consequent to the order of supreme court of India regarding the banning of marketing of fixed dose combination of cortices teriods with other drugs for internal use. Supreme Court of India under SLP. No of 1981 Microlabs (P) Ltd. Vs. Union of India and in a batch of civil application Nos to 2796 of 1982 had ordered on 6/1/1992 and 22/9/1993 respectively that the aggrieved petitioners may place before the DTAB any fresh material in support of their claim for continued marketing of fixed dose combination (FDC) of Corticosteroids with other drugs for internal use before 22/10/1993 and the Board in consultation with an expert in treating Asthma may dispose the representations according to merits within three months from the date of receipt of the representation. 5

6 Ten manufactures submitted representations with available materials with them before 22/10/1993. The copies of the representations and submitted materials alongwith Supreme Court Orders were sent separately to all the Members. As directed by Supreme Court, Dr. D.D.S. Kulpati, Sr. Consultant copies of the material alongwith the representations and Supreme Court Orders were furnished to him. The scientific comments were furnished by Dr. Kulpati. Based on the deliberations and scientific reasoning given by Dr. Kulpati, the members unanimously agreed that Government should reiterate its earlier stand and stick to notification GSR 1057 (e) dated 3/11/1988 i.e. FDC of corticosteroids with any other drugs for internal use should not be permitted. ITEM NO. 4 Consideration of the proposal for prohibition to market certain anti diarrhoeal preparations. WHO Technical Report on The rational use of Drugs in the Management of Acute Diarrhoea in children has shown concern regarding irrational anti-diarrhoeal drugs marketed in the developing countries, leading to draw in on resources & malnutrition among children due to prolonged diarrhoeal disease state. The Expert Committee on weeding out irrational/harmful/sub-therapeutic drugs considered the report and gave its recommendations. These recommendations were based on several scientific paper and after considering the representations of the manufacturers regarding continued marketing of those drugs. The recommendations were also based on several scientific papers which were perused and opinions of several leading Paediatricians and Gastroenterologists in different parts of the country. After deliberations, the members of the DTAB agreed to the WHO view as well as recommendations of the Expert Committee for banning the following paediatric formulations:- a) Anti-diarrhoeals containing absorbents like kaolin, pectin, attapulgite, activated charcoal, etc. b) Anti-diarrhoeals containing non-absorbable, sulphonamides like phthalyl sulphathia zole, sulphaguanidine, succinyl sulphathiazole. c) Anti-diarrhoeals containing Neomycin, Streptomycin and Dihydro-streptomycin, their salts or esters. d) Paediatric anti-diarrhoeals containing antimotility drugs like Diphenoxylates, Loperamide, Atropine or their salts or esters or metabolites, Belladonna, Hypocyamine or their extracts or their alkaloids. e) Fixed dose combination of antidiarrhoeals containing electrolytes. f) Paediatric anti-diarrhoeals containing halogenated hydroxyquinoline. ITEM NO. 5 Consideration of the amendment of notification no. GSR 69 (E) dated 11/2/1991 regarding fixed dose combinations of anthelmintic with cathartic/purgative. 6

7 On the basis of the recommendation of DTAB at its 40 th meeting, the fixed dose combinations of anthelmintic with catriatic/purgative except for Piperazine were prohibited to be marketed, vide Gazette Notification GSR 69(E) dated 11/2/1991. Representation was received regarding the anthelmintic containing santonin with purgative. The Expert Committee after hearing the representation has recommended that the Gazette Notification may be amended as follows: Fixed dose combination of anthelmintic with cathartic/purgative except piperazine and santonin The above amendment is based on the fact that anthelmintic santonin alone is allowed to be marketed and for effectiveness, purgative need to be administered to expel the dead worms. After deliberations, the Members of the Board agreed with the amendment. ITEM NO. 6 Consideration of streamlining of the formulation of patent and proprietary Oral Rehydration Salts (ORS). At present, there are wide variety of formula of patent & proprietary ORS. As per the policy of the Government, Oral rehydration therapy will be the first choice in paediatric diarrhoea management. The P&P ORS marketed are found to vary in their formula in sodium content from 20 to 90 millimoles; Dextrose-Sodium ratio from 1:1 to 1:8 and total osmolarity upto 740 millimoles. Many of them are either not efficacious or suspected harmful in diarrhoea management. The Expert Committee for weeding out irrational/harmful/sub-therapeutic drugs was requested to give their recommendations. The Expert Committee recommended prohibiting marketing of patent and proprietary oral rehyderation salts except those conforming to following parameters: Patent and Proprietary ORS on reconstitution to 1 litre shall contain sodium not less than 50 millimoles and not more than 90 millimoles, the Sodium: Dextrose molar ratio not less than 1:1 and not more than 1:3 and the Total Osmolarity not less than 240 millimoles and not more than 290 millimoles. Patent and Proprietary cereal based ORS on re-constitution to 1 litre shall contain sodium not less than 50 millimoles and not more than 90 millimoles; pre-cooked rice equivalent to not less than 50 gm and not more than 80 gm of rice as total replacement of Dextrose and the Total Osmolarity not more than 290 millosmoles. Patent and Proprietary ORS containing aminoacids may have aminoacids besides IP formula or formula conforming to above parameters and shall claim for treatment of adult chloretic diarrhoea only. The members of the Board desired to know whether sweetening agent, preservative can be added. 7

8 It was clarified that under the 40 th DTAB meeting held on 22/4/1988, it was agreed that the patent and proprietary ORS may contain suitable preservative and sweetening agent which shall neither replace dextrose from the formula nor dextrose/saccharin may be added as sweetening agent. DTAB also felt that freedom from pathogenic organism should also be specified. With this view, Members of the Board agreed to the recommendation made by the Expert Committee as above. ITEM NO. 7 Consideration of amendment of Rule 148 of the Drugs and Cosmetics Rules concerning labeling of cosmetics with composition of ingredients and date of expiry. The Secretary reiterated that further action shall be taken after receiving self-contained note from BIS as agreed under item 1 (2) (a). ITEM NO. 8 Consideration of deletion of clause (iii) of Rule 2 (ee) of the Drugs and Cosmetics Rules, 1945 regarding the definition of registered medical practitioner (RMP). The members agreed, in principle, the deletion of clause (iii) of Rule 2(ee) of Drugs and Cosmetics Rules 1945 regarding definition of RMP. The Chairman, however, advised to enquire from Medical Council of India regarding cut-off date permitted by Medical Council of India which need to mentioned while incorporating a proviso as a saving clause to the persons who although not falling in sub-clause (i) or (ii) but had been registered in a Medical register as persons practicing the modern scientific system of medicines for the purpose of this Act. ITEM NO. 9 Consideration of amendment of Schedule H to the Drugs and Cosmetics Rules, The Secretary explained that DTAB at its 42 nd meeting held on 22/1/1992 constituted a subcommittee to recommend addition/deletion of drugs to Schedule H of the Drugs and Cosmetics Rules, The report of the subcommittee was considered at the 43 rd meeting of the Board held on 29/3/1993 and approved. The Secretary informed the members that it has been felt that many of the potent New Drugs permitted to be marketed in the country merit their inclusion in Schedule H. Likewise, certain drugs which were earlier included in the said Schedule have been deleted by the subcommittee while these are required to be covered under Schedule H. 8

9 In view of the above, a revised list of drugs proposed to be included in Schedule H was placed for consideration of the members. The members after discussion approved the revised list for substituting under Schedule H and to change the words Dangerous Drugs Act to Narcotic Drugs and Psychotropic Substances Act, 1985 wherever occurring in the Drugs and Cosmetics Rules, ITEM NO. 10 Consideration of the revision of Part X of the Drugs and Cosmetics Rules relating to Schedule F&F(1). The Secretary reiterated that the decision taken under item 1 (2) (f) shall be taken into consideration before finalizing the revision etc. of the Part X of the Drugs and Cosmetics Rules, ITEM NO. 11 Consideration of amendment of Rule 149-A to insert a Cautionary Note that children below 7 years should not be allowed to use fluoride tooth paste. The Chairman had urged that in view of the diversity of opinion given on the subject of precautionary note accompanying fluoride toothpaste, the recently introduced Rule 149-A, vide GSR 223(E) dated 19/4/1991, should be again reviewed particularly in consultation with Dental Association and other experts to study the necessity of giving an extra precaution viz. Not to be used by children below 7 years of age. The Chairman would be requested to organize this meeting. The recommendation of DTAB may be sent to the Ministry of Health in the meantime who are carrying out the draft notification concerning the matter. The Chairman asked the Secretary to get opinion from ICMR also. ITEM NO. 12 Amendment of Schedule R of Drugs and Cosmetics Rules in respect of Standards for condoms. The Secretary informed the members that Ministry of Health and Family Welfare issued a draft notification, vide GSR 846(E) dated 4/11/1992, revising the standards of condoms and the same was placed before the last DTAB and was approved by the Board. However, the Government besides receiving large number of comments from the manufacturers was asked by NACO and Family Welfare to include other specifications like Burst Volume etc. in Schedule R so that it is at par with WHO specifications on condoms. As Schedule R was completely revised, Law Ministry advised this Directorate to consult DTAB again. However, because of the urgency of the matter, the Central Govt. had to make rules without consulting the Board. 9

10 The members were requested to examine and discuss the matter before according their concurrence for the said notifications. After discussion, the Board gave its concurrence and approval to the final notification of Schedule R under Drugs and Cosmetics Rules, 1945 in respect of standards for condoms. ITEM NO. 13 Consideration for according protection to those persons who are already declared as qualified persons under Rules 65(15) (c) (ii) of the Drugs and Cosmetics Rules, The Secretary explained that on the basis of the approval granted by the Board at its 42 nd Meeting, Ministry of Health and Family Welfare had published draft notification (GSR 364 (E) dated 2/4/1993) relating to substitution of definition of Qualified persons with the Registered Pharmacist. The Secretary requested the members whether protection in the form of saving clause should be accorded to the persons who are already approved as Qualified Person by the State Licensing Authorities under the said rules. After discussion, the members agreed that proviso under Explanation in clause c to the sub-rule (15) of Rule 65 may be given as under: Provided that the provisions of sub-clause (1) shall not apply to those persons who have been already approved by the licensing authority as Qualified Person on or before the 31/12/1969. SUPPLEMENTARY AGENDA SUPPLEMENTARY ITEM NO. 1. Reconsideration of the question of adoption of standards for ophthalmic preparations laid down under Schedule FF for Homoeopathic Ophthalmic Preparations. The Secretary informed that Ministry of Health and Family Welfare had published a draft notification subsequent to the approval granted by the Board at its 42 nd meeting held on 22/1/1992 to insert new rule 126-B after rule 126-A covering Homoeopathic Ophthalmic Preparation to comply with standards laid down under Schedule FF. It was, however, pointed out by the Law Ministry at the time of vetting that the said category of preparations can be accommodated within rule 126-A itself. The members agreed with the views of Ministry of Law and felt that the proposed amendment of Rule 126-A, as given below, would adequately cover and ensure the standards for Homoeopathic Ophthalmic preparations alongwith standards for Ophthalmic preparations:- 126-A Standards for ophthalmic preparations. The ophthalmic preparations including Homoeopathic ophthalmic preparations shall be those laid down in Schedule FF and such preparations shall also comply with the standards set out in the Second Schedule to the Act. 10

11 SUPPLEMENTARY ITEM NO. 2. Consideration to ban fixed dose combination of tetracycline group of antibiotics with vitamin C. The Secretary pointed out that on the basis of recommendations made by the subcommittee of DCC, the Board in its meeting held on 31/12/1981 had approved prohibition to market Fixed Dose Combination (FDC) of Tetracycline with Vitamin C in lieu of clinical conditions for concomitant usage and marked variation in pharmacokinetic behaviour of these two ingredients. Accordingly, the FDC was prohibited under Section 26 A, vide GSR 578 (E) dated 23/7/1983. In this regard, the Secretary informed the members that a concern has been expressed that FDC of Oxy-Tetracycline with Vitamin C, being manufactured for sale, should also be prohibited under Section 26 A of the Act as pharmacological properties of this combination is almost similar to FDC of Tetracycline with Vitamin C. The Board was requested to opine whether the ban should equally apply to FDC of other Tetracycline with Vitamin C. The Board, after discussion agreed to the proposal that serial No. 12 under notification GSR 578 (E) dated 23/7/1983 should be amended to read as follows:- Fixed dose combination of any Tetracycline groups of Antibiotics with Vitamin C. SUPPLEMENTARY ITEM NO. 3. Consideration to amend rule 49 concerning qualifications of Drug Inspectors. The Secretary informed the members that Central Govt. have amended Rule 49, vide GSR 658 (E) dated 19/10/1993. The qualifications of Inspectors to bring at par with the qualifications under Rules 49A and 50A with respect to licensing and controlling authorities. One of the requirements to be eligible as Inspector is that the person should have degree in Medicine with specialization in Clinical Pharmacology or Microbiology. Clinical Pharmacology and Microbiology is a Post-Graduate qualification where as other disciplines stated in the rule relate to Graduation only. Further, the members also discussed whether protection to those Inspectors who are already in-service and are discharging statutory functions need be given. The members agreed for further amendment of Rule 49 so that the words Clinical Pharmacology and Microbiology may be omitted as Clinical Pharmacology and Microbiology is a post graduate qualification. The experience and other requirements as provided under Rule 49 may continue to remain the same for those Drugs Inspectors who possess qualification as Degree in Medicine. A saving clause for protecting the existing Drugs Inspectors should be given in the form of a proviso proposed as under: 11

12 Provided that the requirements as to the academic qualifications shall not apply to those Inspectors appointed under the Act and who are in position on the date of commencement of the Drugs and Cosmetics (Fourth Amendment) Rules, SUPPLEMENTARY ITEM NO. 4. Consideration of the proposal to amend Schedule J of the Drugs and Cosmetics Rules, 1945 prescribing list of diseases for which a drug may not purport to prevent or cure. The Secretary explained the background to the members that the Board at its meeting held on 22/4/1988 approved a revised list which should be incorporated in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act. The matter intended to be introduced as a bill in the Parliament is being processed by the Ministry of Health and Family Welfare. The Schedule J of the Drugs & Cosmetics Rules also prescribes the list of diseases and ailment which a drug may not purport to prevent or cure. The DCC in its 29 th meeting recommended that Schedule J should also be substituted. The members after discussing the matter accepted the proposal to substitute the Schedule J of the Drugs and Cosmetics Rules, 1945 prescribing the list of diseases for which a drug may not purport to prevent or cure. SUPPLEMENTARY ITEM NO. 5. Consideration of inclusion of bathing bars in Schedule S of the Drugs and Cosmetics Rules. The Secretary informed the members that Soap and Toiletary Industry is marketing Bathing Bars which do not contain TFM but contain Non-soap Synthetic ingredients. The industry claims that the products marketed by them are performance-based and have lather value equal to any other conventional Toilet Soap. The representative from BIS was invited to explain the scientific background of Bathing Bar. The members agreed, in principle, and opined that Bathing Bar should be brought under the purview of Schedule S of Drugs and Cosmetics Rules as BIS has already finalized its standards. However, in the standards for Bathing Bars prepared by them, BIS may consider giving the minimum limit of TFM (Total Fatty Matter) on the label of Bathing Bar. SUPPLEMENTARY ITEM NO. 6. Consideration of amendment to Schedule S to include additional items of cosmetics. The Secretary informed the members that BIS have finalized the specifications for Cosmetics items viz. Lipsalve, Powder Hair Dye, Bindi (Liquid), Kum Kum Powder, Henna Powder for enlarging list of Cosmetics under Schedule S. It was proposed that these cosmetics could be adopted under the said Schedule so that their quality could be ensured in the interest of the consumers. 12

13 After discussion, the members agreed to include the following cosmetics under the purview of Schedule S of the Drugs and Cosmetics Rules: Lipsalve IS:10284 Powder Hair Dye IS:10350 Bindi (Liquid) IS:10998 BumKum Powder IS:10999 Henna Powder IS:11142 SUPPLEMENTARY ITEM NO. 7. Consideration to include human insulin and anti-rabies vaccines with enhanced shelflife period under Schedule P of the Drugs and Cosmetics Rules, The Secretary explained that Pure Insulin (e.g. Human Insulins) and Anti-Rabies Vaccines based on Tissue Culture techniques have been approved and marketed in the country. These new innovations have greater shelf-life period than what is already stipulated in Schedule P. These drugs having larger shelf-life would be required to be included in Schedule P. The members agreed to the recommendations made by the 29 th DCC held on 6 th and 7 th January, 1994 that pure Insulin, Human Insulin and newer anti-rabies vaccines be included in Schedule P of the Drugs and Cosmetics Rules with an enhanced shelf-life period (life period of months for newer anti-rabies vaccines and 30 months for newer Insulin) incorporating their shelf-life proportionate to the temperature gradient. 13

14 SUPPLEMENTARY ITEM NO. 8. Consideration to amend rule 96 to include assigning of date of expiry to bulk drugs under Schedule P of the Drugs and Cosmetics Rules, The Secretary explained to the members that rule 96 provides that drugs specified in Schedule P and their preparations including combinations with other drugs are required to bear on their label the date of expiry as laid down in the said Schedule. The members were asked to opine whether rule 96 requires any changes so as to have an effective control on date of expiry of bulk drugs. The members agreed that necessary amendment under clause (vii) to sub-rule (1) of rule 96 may be made to enlarge the meaning of the word Drug preparations to read as Drugs and their preparations. SUPPLEMENTARY ITEM NO. 9. Consideration to restrict to express contents of liquid oral preparations in terms of 5 milli litre (Ml.) under Rule 96 of Drugs and Cosmetics Rules, The Secretary explained that presently certain dosage forms viz Liquid Oral Preparations contain active ingredients in terms of one or two table spoonful (i.e. 15 to 30 m.l.) whereas it is more convenient to express formulations containing active ingredients in terms of 5 ml. Rule 96 mentions that the labels of the Liquid preparations can express ingredients as 5 ml. or in multiples thereof. The members were requested to examine whether such preparations should be restricted to express active ingredients in terms of one teaspoonful (i.e. 5 ml.) only. DTAB agreed to amend entry (a) to clause (iii) of sub-rule (1) to Rule 96 as recommended by DCC and the words or multiple thereof should be deleted so that the contents for liquid oral preparations in terms of 5 ml. are expressed only. SUPPLEMENTARY ITEM NO. 10. Consideration to amend the Drugs and Cosmetics Rules to streamline the procedures for grant and renewal of licences in respect of drugs like blood and blood components, sera and vaccines and LVPs for which Central Govt. is also a Licence Approving Authority. The Secretary explained to the members that they may recall that Central Govt. have assumed powers in matters relating to grant or renewal licences to manufacture LVPs, Whole Human Blood etc. The Ministry of Health and Family Welfare published two notifications vide GSR 28 (E) dated 22/1/1993 and GSR 923 (E) dated 14/12/1992 through which Drugs Controller (India), as CLAA, can exercise simultaneous jurisdiction in matters relating to licensing of Notified drugs. In these notifications, certain procedures have been laid down for the State Licensing Authority as well as CLAA before the grant or renewal of licences for the said notified drugs. 14

15 The DCC at its meeting held on 6 th & 7 th January, 1994 discussed the procedure which should be followed at the time of grant or renewal of licences as well as at the time of inspection of the firms who intend to renew or seek licences from the regulatory authority. The following changes / provisions were proposed to be made :- (a) (b) (c) (d) Explanation to Rule 122 (F); provision under clause (4) to Rule 122 (F) regarding procedure and action thereof on receipt of application by the State Licensing Authority. Rule 122 F(5) needs amendment with regard to sending report to CLAA by the SLA which may include duly signed licences by the SLA for perusal of CLAA and its approval and subsequent intimation. Form 27(C) requires amendment to include the location as well as name and address of the applicant. Necessary changes may also be made in regard to the licensing of other drugs (LVPs, Sera and Vaccine etc.) by amending Rules 68A, 81, 82, 83, 84A and Schedule A so as to make procedure uniform for all drugs covered under Central Licensing System. The members after discussion agreed and approved the changes intended to be incorporated for streamlining and rationalizing the mode of application; procedure to be followed by the SLA; examination of the report and then forwarding to the CLAA; procedure to be adopted by the State as well as Central Licensing authorities for grant / renewal of licences. SUPPLEMENTARY ITEM NO. 10-B Consideration to amend the Drugs and Cosmetics Rules for prescribing fees and forms separately for LVPs / Sera and Vaccines under Rules 75, 76, 77, 78, 81, 83, 84A and Schedule A. On the basis of the recommendations of DCC held on 6 th & 7 th January, 1994, the members agreed for prescribing different Forms for LVPs, Sera and Vaccines under Rules 75, 76, 77, 81, 83, 84A and Schedule A together with the definition of LVPs as well as separate provision for fee structure for LVPs / Sera and Vaccines under the relevant rules of the Drugs and Cosmetics Rules,

16 SUPPLEMENTARY ITEM NO. 11. Consideration of the report of the Expert Standing Committee constituted by 28 th DCC regarding (A) Minimum area with regard to retail sale of drugs under Rule 64. (B) Provision for having separate area for formulation meant for external use and internal use under Schedule M. (C) Inserting additional qualification under Rule 64(2) for competent person in respect of sale of drugs by way of whole sale. The Secretary explained that consequent to various queries raised by the State Licensing Authorities, the 28 th DCC constituted an Expert Standing Committee to examine the above aspects and give its recommendations. The Committee opined as under : A.1) An area not less than 16 sq. mt. wherever licences in respect of both wholesale and retail are granted in the same premises should be specified under Rule 64 in addition to the area already specified in the said rule in accordance with the Schedule N. 2) For retail licences in Forms 20 and 21, the area should be not less than 10 sq. mt. The members discussed the matter and approved the recommendations of DCC. However, the members felt that while amending the said rule in respect of above, necessary protection in the form of proviso as is available for wholesale of drugs may be provided to the persons who have already been licensed by the Licensing authorities. (B) (C) The members after discussion agreed that suitable changes in the form of proviso or as a Note at the end of the Schedule M may be inserted in this regard. The Secretary desired that members may consider whether qualifications of competent person for sale of drugs by way of wholesale as well as his experience should be laid down as per the recommendations of the Committee. The members agreed that while amending the provisions relating to competent person, the qualification of personnel having a Degree of a recognized University in any faculty and having experience of one year in dealing with drugs should be incorporated. SUPPLEMENTARY ITEM NO. 12. Consideration of the question of omitting provision relating to setting up of testing laboratory by the cosmetic manufactures under Schedule M-II. The Secretary explained that Ministry of Health and Family Welfare published notification, vide GSR 723 (E) dated 11/8/1992, and inserted under Rule 139(2), a Schedule M-II stipulating requirements of premises, plant and equipments, area and other GMPs regarding various categories of cosmetics. Based on the recommendations of the earlier subcommittee of DCC, provision was made in the Schedule itself that a testing laboratory should be provided by each licensee. A concern has been expressed that a necessary provision should have been provided under the rules. 16

17 The members may consider whether the provision of testing laboratory should be incorporated in the rules instead of having been mentioned under the said Schedule. After discussion, the members felt that sub-rule (5) to rule 139 having clauses (i) and (ii) be substituted with the provision that each licensee shall have a testing facilities in its own premises but cosmetics requiring testing by sophisticated instrumentation techniques may be permitted to be tested at the Institutions approved by the State Licensing Authorities. SUPPLEMENTARY ITEM NO. 13. Consideration of revision of fee under Schedule B for testing of samples of drugs by Govt. Laboratories. The Secretary explained to the members that Schedule B to the Drugs and Cosmetics Rules, 1945 prescribe testing fee structure for various categories of drugs whose samples are sent to the Analyst for testing by the State as well as Central Government. The Secretary stated that Schedule B was incorporated way back in 1978 and the fees prescribed have not been revised since then inspite of the fact that in-puts like salary of the personnels, prices of the chemicals and equipments requiring sophisticated instrumentation techniques or biological or micro-biological methods conducted by Govt. Institutions have increased manifold. Further, the intention of the legislation in revising the fees structure is not with a profitable pecuniary motive but to commensurate with the changes least required for the purpose. After careful consideration, the members agreed and approved that the fees structure proposed for Schedule B may be substituted for the purpose. SUPPLEMENTARY ITEM NO. 14. Consideration of proposal to give representation to members of registered consumers association in DTAB to advise Central Govt. on all technical matters. The Secretary explained that in case W.P of 1983 Vincent Panikulangara Vs. Union of India, the Hon ble Supreme Court of India ordered dated 3/3/1987 that adequate representation should be provided to consumers and atleast two capable representatives from out of their category should be nominated by the Central Govt. The manning of the Board should be such that in its functioning it would in a position to effectively advise the Central Govt. on all technical matters. The Secretary requested the members to discuss the proposal and advise accordingly. After discussion, the Board felt that the judgement may be examined in consultation with the Ministry of Health/Ministry of Law. While referring the matter, the functions of the respective bodies (DCC and DTAB) as stipulated under the Drugs and Cosmetics Act, 1940 may also be brought to their notice so that further course of action to implement the direction of the Supreme Court could be initiated. SUPPLEMENTARY ITEM NO

18 Consideration of proposal to amend Rule 85 to empower licensing authority to direct the manufacturers to stop manufacturing and also to empower to destroy drugs unfit for use where no legal action is contemplated. The Secretary explained to the members that subsequent to the recommendations of the Drugs Consultative Committee to include in Rule 85 so as to empower to regulatory authorities to stop manufacturing as well as destroy drugs considered unfit for use. It is for consideration whether such provision could be incorporated under sub-rule (i) as well as subrule (2) of the principal rule itself. The members may discuss and give their recommendations in the matter. The members discussed the matter and agreed that the principal rule with respect to its two sub-rules may be suitably amended so that both the regulatory authorities under the rule could be empowered on the said matter. While amending the rule, the provision may also be made whereby the licensees whose license has been suspended or canceled or whose drug has been stopped for manufacture, sale or distribution or destruction may within the stipulated period from the date of the order could prefer a appeal against that order to the Central Govt. or the State Govt. so that the mechanism of natural justice could be incorporated in the said rule. This provision is being made as the same is available in analogous licences of sales, Cosmetics, Homeopathic, Ayurvedic etc. The meeting terminated with a vote of thanks to the Chair. 18