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Biological Drugs

All function of NCLB are now under DRAP Act, 2012 (Act No. XXI of 2012) and all previous actions and SROs are protected.

Lot Release is now under Schedule I, and NCLB is part of DRAP under Section 3 of this Act.

For detailed description of various aspects of DRAP Act, 2012 visit this link

Http://www.drap.org.pk

DRAP Act, 2012 pdf file. 

 

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Schedule I, of DRAP Act, 2012

SCHEDULE-I

[see clauses (v), (xii),(xviii), (xix) and (xxviii) of section 2 of DRAP Act, 2012]

 1.         BIOLOGICALS include-

(1)        biological drugs produced by biological systems and which require standardization by biological assays according to the relevant and updated recommendations of the World Health Organization published in Technical Report Series and Biological Standardization Report and includes,-

 (a)      blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clotting Factors Tractions, Fibrinogens, Immunoglobulins;

 (b)      immunological products including Antisera, Antitoxins, specific Immunoglobulins:

 (c)      in vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, Coccidioidin, Allergens, Allergens Extracts, Antibodies conjugated with isotopes for imaging studies;

 (d)     antigens, cytokines/antibodies/cells injected to elicit a biological response;

 (e)      vaccines, including:

                                                                 (i)            bacterial vaccines including live, killed whole cell, protein sub-unit, polysacchride or glyco-conjugate, toxin

                             derivatives, and rDNA biotechnology developed;

                                                               (ii)            viral vaccines including live, inactivated, sub-unit, rDNA, conjugated;

                                                             (iii)            polyvalent combinations of vaccines containing combination of vaccines defined in  e (i) and d(ii).

(f)      toxins and venoms including snake venoms, scorpion venoms etc;

 (g)     immunostimulants of biological origin including BCG vaccine for immunotherapy;

 (h)     biotechnology products which are primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology or other processes involving site specific genetic manipulation techniques;

 (i)       human interferons, natural hormones, recombinant antibodies, monoclonal antibodies and derivatives gene therapy products.

 (2)        “biological drugs (finished form)”, are biological drugs that are defined in sub-paragraph (1) above and are manufactured, packed by the manufacturer under his responsibility of quality assurance and is further released by the National Control Authority or the National Control Laboratory of the country of origin under the World Health Organization’s Lot Release system of evaluation.

 (3)        “biological drugs (ready-to-fill form)”, are biological drugs that are defined in sub-paragraph (1) above but are manufactured at one site in the form of a “Ready-to-fill Bulk” but are transferred to another site for final filling, labeling, packaging and quality control of the finished form. No further formulation or dilution of the ready-to-fill bulk is allowed in this case of manufacture. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.

(4)        “biological drugs (concentrated form)”, are biological drugs that are defined in sub-paragraph (1) above that are manufactured at one site but are stored in the form of Concentrated-Bulk of the active ingredient at controlled temperatures. Such Concentrated-Bulk may be transferred to any other site under temperature controlled conditions for further dilution, stabilization, filling and packaging. The diluted and stabilized bulk requires its own set of quality control test and the final finished form of such biological drugs undergo another set of complete quality control tests. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.

(5)        “biological drugs (naked vials)”, are biologicals drugs that are defined in sub-paragraph (1) above that are manufactured and filled at one site but the final containers are neither labeled nor packed in cartons. These drugs are imported in unlabeled vials and are labeled and packed in carton locally. In such cases at least an identity test is required to confirm the positive identification of the required antigen. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.

(6)        Originator biological drugs means a biological drug which has been licensed by the national regulatory authorities on the basis of a full registration dossier, i.e. the approved indications for use were granted on the basis of full quality, efficacy and safety data:

 (a)                reference biotherapeutic product (RBP) means an originator biological drug product that was licensed on the basis of a full registration dossier. It does not refer to measurement standards such as international, pharmacopoeial, or national standards or reference standards;

 (b)               biosimilar biological drugs mean Similar Biotherapeutic Product (SBP) which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product;

 (c)                similarity means absence of a relevant difference in the parameter of interest.

 (7)        No human biological drug is allowed sale and use until a “Lot Release Certificate” from the Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has been obtained.

 (8)        Pharmaceutical dossier includes a set of documents submitted by a person for the registration of a therapeutic good, containing complete information about-

(a)                master formula;

(b)               all ingredients both active pharmaceutical ingredients and inactive excipients added with their safety profile data;

(c)               complete manufacturing procedure of the drug, biological or medical device;

(d)              quality control steps and procedures at each level of raw material selection, in-process testing, finished drug testing, and stability testing;

(e)               clinical trial data and published reports about the safety and efficacy of the drug;

(f)                complete details of manufacturing plant and equipment, quality control laboratories and equipment;

(g)               ware-houses capacities and facilities; details of human resources available and the latest cGMP report shall also be part of this document set;

(h)               any other information required by the registration board for establishing the safety, efficacy, bioavailability, bioequivalence, or biosimilarity of the drug.

2. DRUG includes-

(a)      any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals, including substance used or prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic, Chinese or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed;

(b)      abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solution;

(c)      such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism as cause, carry or transmit disease in human beings or animals or for disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored;

(d)     such pesticides as may cause health hazard to the public;

(e)      any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States  Pharmacopoeia or  the  National  Formulary  of  the United  States, whether alone or  in combination   with   any  substance    exclusively   used  in the   Unani,   Ayurvedic, Homoeopathic, Chinese or Biochemic system of treatment, and intended to be used for any of  the purposes mentioned in sub-clauses (a), (b) and (c); and

(f)      any other substance which the Federal Government may by notification in the official Gazette, declare to be a drug for the purpose of this Act.

 

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