Ministry of National Health Services, Regulations and Coordination
Drug Regulatory Authority of Pakistan
National Control Laboratory for Biologicals
NCLB implements Lot release and Lab testing of Biological Drugs as per Schedule I of DRAP Act, 2012 (Act No. XXI of 2012)
and is part of DRAP Authority under Section 3 of this Act.
Schedule I, of DRAP Act, 2012
[see clauses (v), (xii),(xviii), (xix) and (xxviii) of section 2 of DRAP Act, 2012]
(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,-
(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;
“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
“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
(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) 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.
3. MEDICAL DEVICES include,-
(a) instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease; or
(b) any other item which the Federal Government may, by notification in the official Gazette, declare as medical device;
4. MEDICATED COSMETICS include,- Cosmetics containing drugs and are defined as articles containing active drug ingredients intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to human body or part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.
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