The Drugs Act, 1976 (the 1976 Act) is the underlying legislation for the import, export, manufacture, distribution and sales of drugs in Pakistan. The Drugs Regulatory Authority of Pakistan Act, 2012 (the 2012 Act) was subsequently passed for the effective coordination and enforcement of the 1976 Act and for the endorsement and systematic implementation of international treaty obligations, including with respect to 'therapeutic goods'.2 The 2012 Act is the controlling statute, operating as unified law across all provincial boundaries.3
The 2012 Act established the Drug Regulatory Authority of Pakistan (DRAP), which comprises the Policy Board,4 the Central Licensing Board (CLB), the Registration Board (RB) and the Provincial Quality Control Board. DRAP is recognised as the national competent authority for medicines and medical devices.
II THE REGULATORY REGIME
Following the 18th amendment to the Constitution of Pakistan 1973, drugs and medicines do not fall within the ambit of federal legislation. However pursuant to Article 144 of the Constitution, Parliament may legislate on provincial matters by invitation and to the extent so conferred. The provincial governments may therefore amend or repeal any law in respect of competences that are exclusive to the provinces, or otherwise curtail or withdraw the invitation.
Each of the provincial assemblies has validly conferred the power to legislate in respect of drugs and medicines to Parliament, which promulgated the 2012 Act.
The term 'drug' is defined widely to include:
- 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 disease, an abnormal physical state, or the symptoms thereof in human beings or animals;
- abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solutions;
- 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; and
- any substance mentioned as a monograph or as a preparation in the Pakistan Pharmacopoeia, the Pakistan National Formulary, the International Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, 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 or biochemic system of treatment, and intended to be used for the above purposes (a) to (c).
Medical devices include: instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease.5 The 2012 Act also extends in scope to biologicals, as well as to health and over-the-counter non-prescription products such as probiotics and disinfectants, nutritional products, food supplements, baby milk and foods, medicated cosmetics, medicated soaps and medicated shampoos. A determination as to whether a product falls within the scope of the applicable legislation is factual and based on the purported health related purpose thereof and whether it is presented in pharmaceutical dosage forms.6
The Medical Devices Rules, 2017 (the MDR Rules) govern the manufacture, import and sale of medical devices. The Alternative Medicines and Health Products (Enlistment) Rules, 2014 (the Alternative Medicines Rules) govern the licensing and registration of alternative medicines (such as Chinese, Unani, Ayurvedic and homeopathic) and health and over-the-counter non-prescription products. All other drugs are registered and licensed in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976 (the Licensing Rules).
ii Non-clinical studies
The Drugs (Research) Rules, 1978 (the Research Rules) govern the research, development and evaluation of drugs. Any research in drugs is required to be conducted at such places and by such persons as are approved by the federal government and are categorised as: (1) clinical trials; and (2) other than clinical trials.7
The Division of Quality Assurance and Laboratory Testing of DRAP is responsible for the enforcement of good manufacturing practices and for the testing and research of drugs, with an aim to implement guidelines respectively of the World Health Organization (WHO), International Conference on Harmonization and the Food and Drug Administration.
Any research on aspects other than clinical trials are to be conducted under the supervision of a person who possesses postgraduate qualifications and experience in the relevant field and has sufficient background to conduct scientific investigation. Progress regarding the investigation is to be submitted to the federal government at regular intervals, not exceeding six months.8 Further, experts authorised by the federal government must be allowed to visit the premises where the research is being conducted.
iii Clinical trials
The Bio-Study Rules, 2017 (the Bio-Study Rules) regulate the safety, quality, efficacy, handling and use of investigational products in clinical trials. A clinical trial requires a licence for the trial site and the clinical studies.9 An approval must also be sought from the National Bio Ethics Committee of Pakistan Health Research Council (NBC-HRC). Additionally, the institutional review board or the institutional review committee of public or private health institutions is responsible for ethical clearance and periodic review of the clinical trial being carried out at the institution, as well as for submission of reports to the committee formed under the Bio-Study Rules.10
Conditions for a clinical trial include:
- each investigational product or trial material must be labelled as 'caution: for investigational use only' and 'not for sale';11
- quarterly reports of results obtained and the final results from the clinical trials are required to be furnished to the clinical studies committee;12 and
- a database of subjects recruited or enrolled for the study or trial must be maintained.13
In addition to the requirements set out for non-clinical studies (above), research during clinical trials is to be conducted in stages as follows: stage 1 – on human beings to determine the single and short-term multiple dosing for tolerance, side effects, toxicity, metabolism, preferred routes of administration, safe dosage range and other pharmacological actions of the drug; stage 2 – to determine the safety and effectiveness, including the effective dose range, the common side effects of the drug on both clinical and laboratory parameters and, where possible, the level of the drug in biological fluids in relation to therapeutic response; provided that these studies shall be undertaken if studies in stage 1 of the investigation demonstrate satisfactory results, and shall involve initial and limited use of the drug in the treatment or prevention of the disease for which the drug is intended, which shall be administered to carefully supervised patients; and stage 3 – to be conducted under controlled conditions in order to expand knowledge of potential use and hazards and shall be undertaken if the data obtained in the above stages provides reasonable assurance of safety and effectiveness, or suggests that the drug may have a potential value of conducting several trials outweighing its hazards; provided that these studies shall be carefully monitored and all possible precautions shall be taken to prevent unnecessary exposure of the patient to the risk.14
Studies on children shall not be undertaken unless there is a possibility of benefit to them and adequate studies of safety and efficacy are available in adults.
Small quantities of medical devices, components or raw materials for the purpose of clinical investigation may be imported and an application for such import is required to be made.15 A clinical investigation using a medical device cannot be carried out unless the appropriate label has been provided.16 Labels must be in English, but some labels for devices intended for use at home may be in Urdu.
iv Named-patient and compassionate use procedures
A licence for import, manufacture and/or sale of drugs does not apply to drugs for personal use.17 Further, anti-cancer drugs, cardiac drugs and any essential life-saving drugs imported for use in hospitals and institutions are not required to be registered under the 1976 Act provided, inter alia, that such drugs:
- have the prior approval of the CLB;
- are not sold or distributed in the market;
- are on free sale in the country of origin, except for life-saving vaccines and anti-sera for human use only, where pre-qualification by the WHO or approval of any regulatory authorities as defined by the RB is provided; and
- are used for therapeutic purpose in hospitals or institutions only and not for clinical trials, examination, test or analysis.18
Small quantities of medical devices may be imported for the use of hospital patients, including those that are not enlisted or registered with DRAP, subject to conditions, including:
- the medical device shall form part of a passenger's bona fide baggage and shall be intended for exclusive personal use;
- the quantity shall be restricted to meet personal requirements only; and
- any medical device whose import is prohibited on account of lack of enlistment or registration may be imported for hospital use subject to prior approval from the Medical Device Board of DRAP (MDB) and upon compliance with conditions imposed by it.19
v Pre-market clearance
Where there is an unmet need for unregistered drugs, an application may be made to DRAP for: (1) consideration of such drugs on a priority level; and (2) conditional registration or marketing authorisation.20
The following criteria must be met for expediting the assessment of a drug:
- benefit-risk balance of the product is positive;
- unmet medical needs will be followed;
- the benefit to the public health of the drug product's immediate availability on the market outweighs the risk; and
- it is likely that the applicant will be able to provide comprehensive data.
To be eligible for a priority review, the drug must be:
- for the treatment of rare diseases;
- a new drug molecule or new indication drug;
- short in availability; and
- for a severe condition (e.g., outbreak of a disease).
Drugs that are not registered may apply for conditional marketing authorisation if: (1) the drug is aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases; and (2) required in a public health emergency.
vi Regulatory incentives
An invention is patentable if it is new, involves an inventive step and is capable of industrial application.21 Invention, as defined in the Patents Ordinance, 2000 (the 2002 Ordinance), includes any new and useful product, including chemical products and any substance, article, apparatus, and machine. The rights holder can derive exclusive benefits and exclude others from making, selling, stocking, using, etc., their invention for 20 years.22 During this period, the rights holder can use their invention or, if they so desire, license it to others.
vii Post-approval controls
Section 6 of the 1976 Act provides that the provincial governments shall regulate the sale of drugs and may, for this purpose, make orders and issue directions to importers, manufacturers, stockists, retailers and other dealers of drugs.
Under the MDR Rules, a manufacturer must establish, maintain and implement a post-market surveillance system. The conditions of an establishment licence include that the manufacturer establish an independent quality control department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of safety, quality and performance of the medical device being or to be used in the manufacture.23 Additionally, the manufacturer shall, on demand from the MDB, direct that every batch, or specific batches, of medical devices specify a sample for examination and if required, furnish full protocols of the tests applied.24 Furthermore, a manufacturer is required to comply with all applicable good manufacturing practices, good distribution practices and good storage practices.25
The Alternative Medicines Rules provide that each enlistment holder (manufacturer or importer) is responsible for and liable for the quality, safety and efficacy of the authorised enlisted product, and is responsible for following the principles of good manufacturing practices. Additionally, manufacturing, quality control, sale and distribution records are to be maintained for one year after the expiry of the finished product.26
viii Manufacturing controls
A licence from the Health Department of the relevant provincial government is required to manufacture drugs in Pakistan.27 The manufacture of drugs is regulated under the Licensing Rules. Rule 3 of the Licensing Rules sets out the different types of licences to manufacture, which are: (1) basic manufacture;28 (2) semi-basic manufacture;29 (3) formulation;30 (4) repacking;31 and (5) for experimental purposes. Specific conditions are set out in detail in the Licensing Rules.
Rules 26 and 28 of the Licensing Rules provide the mechanism for registration of a drug. If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each.32 Any licence granted under the Licensing Rules is valid for a period of five years, unless suspended or cancelled earlier, and may be renewed for another period of five years.33
An application for registration shall be made to the Secretary of the RB. The Licensing Rules set out certain conditions that must be met for a registered drug, including:
- the import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the RB, in accordance with such amended information (provided deviations may only be made after obtaining prior approval of the RB);
- the indications, contra-indications, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug, are clearly specified in the labelling and promotion;
- every drug is produced in sufficient quantity so as to ensure its regular and adequate supply in the market; and
- manufacture of a drug may not be discontinued without prior approval of the RB.34
A licence to manufacture medical devices must be procured from the MDB.35 Any licence issued by the MDB shall be subject to conditions, including:
- manufacturing to be conducted under the active directions and personal supervision of competent technical staff consisting of at least one person, being the production in-charge, who shall be a full-time employee and who has a degree in either pharmacy or bio-engineering and at least four years of experience in manufacturing medical devices or pharmaceuticals; and
- establishment of a quality control department and to maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the safety, quality and performance of the medical device being, or to be used in the manufacture.
With respect to alternative medicine, an application is required to be made to DRAP for enlistment.36 The following are eligible to apply for enlistment: (1) manufacturers with manufacturing and quality control facilities; (2) 'givers' of manufacturing contracts (if applicable); (3) importers authorised by the overseas principal manufacturer; and (4) manufacturers with existing manufacturing licences.37
Baby milk and foods, nutritional products and probiotics shall be manufactured and tested in accordance with internationally recognised standards, codes of practice, guidelines and recommendations of the Codex Alimentarius.38 A warranty is required to be issued by the enlistment holder or authorised agent stating that the products do not contravene the 2012 Act.39
ix Advertising and promotion
No person may advertise any drug, any substance used or prepared for use in accordance with the Ayurvedic, Unani, homeopathic, or bio-chemic system of treatment (or any other substance or mixture of substances as may be prescribed), or any remedy or treatment, or offer a treatment for any disease, without prior permission.40 The term 'advertise' means to make any representation by any means whatsoever for the purpose of promoting (whether directly or indirectly) the sale or disposal of a drug, a substance or a mixture of substance, a remedy or a treatment.
Rule 31 of the Licensing Rules provides that the federal government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, any substance or remedy, and may approve the contents of such advertisement subject to certain conditions. An advertisement cannot contain any direct or indirect comparison in any way with any other drug, substance or remedy for any disease, for the purpose of attracting customers or with a view to discrediting another product.41 Further, no advertisement, sampling or promotional activity in respect of drugs shall exceed 5 per cent of the turnover of the manufacturer.42 Lastly, a retailer's discount is capped at 15 per cent of the maximum retail price.43
An application to the MDB is required to be made before advertising a medical device to the general public.44 The MDB may permit the advertisement of a medical device, approve the contents of the same and specify conditions subject to which such advertisement may be made, including that no direct or indirect comparison can be made with any other medical device for the purpose of attracting customers or with a view to discrediting the other product. The advertisement shall include information or any risks or other precautions as may be necessary for the protection of public health, as well as the maximum retail price.45 No approval from the MDB is required if a medical device is advertised to the medical, pharmaceutical and allied professions, through medical representatives or through professional journals and publications that are meant for circulation exclusively among the members of these professions; provided, however, that a copy of such journal or publication shall be sent to the Division of Medical Devices and Medicated Cosmetics.
The Alternative Medicines Rules provide that no person may issue or cause to be issued any advertisement without obtaining permission for the content of the advertisement material.46
x Distributors and wholesalers
In Pakistan, drug manufacturing companies do not generally sell medications directly to retail outlets. They instead appoint distributors and wholesalers to supply drugs to the retailers from where drugs are dispensed to the patient. Pursuant to Section 23 of the 1976 Act, no person can sell any drug without a licence or without a warranty in the prescribed form, bearing the name and batch number of the drug issued. Further, a drug cannot be distributed as a sample except in accordance with any conditions as may be prescribed by DRAP.47
A medical device cannot also be placed in the market unless it has been appropriately labelled.48
With respect to alternative medicines and health products, enlistment holders may authorise distributors as authorised agents for the supply and sale of finished alternative medicine and health products and such distributors are required to issue a statement, on behalf of the enlistment holder, that the products do not contravene the 2012 Act.49
xi Classification of products
Based on the Essential Medicines List of the WHO, the National Essential Medicines List of Pakistan provides a core list of the minimum needs of a basic healthcare system. The medicines are classified based on symbols, which indicate:
- clinical performance within a class of pharmaceuticals;
- any age or weight restrictions;
- medicines that require specialist diagnostic or monitoring facilities;
- individual medicine or strength of medicine to be restricted when used for children; and
- medicine recommended for use at primary, secondary and tertiary level.50
The Drugs (Labelling and Packing) Rules, 1986 set out separate requirements for the labelling of products, which depend on the intended consumer.
Classification and grouping of medical devices has been harmonised with international guidelines of the WHO, the International Medical Devices Regulators Forum and the Asian Harmonization Working Party.51
xii Imports and exports
A licence from DRAP is required by a manufacturer to export, import or manufacture for sale, or sell any drug.52
The Drugs (Import and Export) Rules, 1976 (the Import and Export Rules) provide the mechanism for obtaining licences for the import and export of finished drugs. Licences are also issued for a period of two years, unless suspended or cancelled earlier, for the import and export of: drugs other than finished drugs; and for small quantities of drugs for the purpose of clinical trial, examination, tests or analysis.53
A medical device may be imported subject to the condition that the importer: (1) shall possess a valid medical device establishment licence and medical device enlistment or registration; and (2) have premises for proper storage to preserve its properties.54 General conditions (except where such import is for personal or hospital use), include: (1) to supply a copy of the test report of the medical device or component or raw material from the manufacturer; and (2) provide an undertaking that the quality and safety of the medical devices, components or raw materials and their genuineness is in accordance with the MDR Rules.55
Medical devices cannot be exported without the approval of the MDB.56 A permit to export medical devices, unless suspended or cancelled earlier, shall be valid for three years.57 A permit for the export of medical devices is subject to certain conditions, including that:
- the permit holder shall furnish to the MDB (if so demanded) from every batch or lot, as may be directed, samples in such quantity as the authority may consider adequate for any examination, test or analysis to be made and the permit holder shall, if so required, furnish full protocols of such tests as may have been applied; and
- the permit holder shall, on being informed by the MDB that any part of any batch or lot of a medical device has been found not to conform to the required specifications and on being directed so to do, withdraw the remainder of that batch or lot from export.
xiii Controlled substances
The Control of Narcotic Substances Act, 1997 (the Narcotics Act) regulates controlled substances, narcotics and psychotropics in Pakistan. Controlled substances are defined as any substance that may be used for the production or manufacture of narcotic drugs or psychotropic substance.58 A 'narcotic drug' includes all manufactured drugs.59 A comprehensive list of 'psychotropic substance[s]' is included in the Narcotics Act.60
The possession, manufacture, extract, preparation or any offer for sale, purchase, distribution or delivery of a narcotic drug, psychotropic substance or a controlled substance is prohibited unless it is for medical, scientific or industrial purposes.61 Additionally, the import, export, transport or transhipment thereof is prohibited, unless in accordance with special rules framed by the government of Pakistan in this regard.62
Pursuant to the 2012 Act, the Controlled Drugs Division of DRAP, in consultation with the federal government, is responsible for regulating and allocating quotas for narcotic drugs, psychotropic substances and precursor chemicals and to perform other functions connected therewith.
The federal government or a provincial government may, by notification in the Official Gazette of Pakistan (the Gazette), appoint such persons as it thinks fit, having the prescribed qualifications to be federal inspectors, or as the case may be, provincial inspectors within such local limits as it may assign to them.63
Section 18 of the 1976 Act provides that an inspector may: (1) inspect any premises wherein any drug is manufactured, stored, exhibited for sale, or distributed; the plant and process of manufacture and the storage arrangements; the means employed for standardising and testing the drugs and all relevant records and registers; and (2) take samples of any drugs that are being manufactured, sold, stocked or exhibited. In event of a contravention, a provincial inspector shall refer the matter to the provincial quality control board and seek orders as to the action to be taken in respect of such contravention; in the case of federal inspectors, such referral shall be made to the CLB or the RB.64
The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 (the Inspectors Rules) set out the qualifications and duties of a federal inspector.
The duties of a federal inspector include, to:
- inspect, at least twice a year, all premises licensed for the manufacture of drugs including the plant and the process of manufacture and the methods and places of storage;
- take samples of any drugs that are suspected to be manufactured, stocked, sold or exhibited for sale in contravention of the provisions of the 1976 Act;
- institute prosecutions in respect of breaches of the 1976 Act; and
- conduct surveillance of marketed drugs for ensuring quality control.
III PRICING AND REIMBURSEMENT
The federal government may, by notification in the Gazette, fix the maximum price at which any drug specified is to be sold.65 The mechanism for the fixation of prices of various therapeutic goods and the regulation thereof is carried out by DRAP.
Rule 3 of the Drugs Discounts and Price Adjustment Rules, 2006 (the Pricing Rules) provides that '[n]o company or firm or proprietor shall allow a sum of all discounts, in cash, kind or both, exceeding forty percent of the maximum retail price printed on the pack of the drug.' Rule 4 of the Pricing Rules provides that the adjustment of prices of registered drugs shall be subject to the following conditions:
- downward or upward adjustments of the drug prices shall take place within the maximum retail price fixed;
- the company shall make upward or downward adjustments in prices, if they so desire, after the expiry of one year from the date of last adjustment;
- the Ministry of Health shall be informed in advance of the adjustment in prices and the effective date for such adjusted price; and
- there shall be no other change in the approved labelling of the drug.
Further, the Pricing Policy, 2018 (the Pricing Policy) sets out the pricing mechanism with respect to allopathic drugs, including biologicals for human use only, which are to be divided into two categories: (1) drugs and biologicals on the National Essential Medicines List; and (2) all other drugs.66
The price of a drug cannot exceed the maximum retail price.67 Further, the price of a generic drug cannot exceed the maximum retail price of the respective originator brand, except when the originator brand has made a request for de-registration or it has been confirmed from the manufacturer or importer of the originator brand that it can no longer ensure adequate availability of the drug, due to non-viability of the same.68
With respect to medical devices, Rule 14 of the MDR Rules states that when making an application for enlistment and registration of a medical device, the applicant shall propose a maximum retail price for the medical device sought to be registered.
IV ADMINISTRATIVE AND JUDICIAL REMEDIES
Any export, import, manufacture for sale, or sale of any spurious drug or unregistered drug, or manufacture for sale or import of any drug without a licence, is punishable with imprisonment and a fine. Additionally, the drug court may order forfeiture of any stock of drug or substance or any implements used in the manufacture or sale of such drugs and any receptacles, packages or coverings in which such drug is contained and the mode of transporting such drugs.69
Any contravention of the 1976 Act in relation to the import, export, manufacture or sale, which in the opinion of the licensing authority or the CLB is likely to endanger public health, may result in a cancellation or suspension of a licence.70 Any contravention may also lead to cancellation of the registration of the drug or suspension of the same for a specified period.71
Further, if a corporate entity is guilty of an offence, then each director, partner and employee of the corporate body with whose knowledge or consent the offence was committed, is also be guilty.72 If any person is convicted of an offence, the Drug Court may publish the offender's name, place of residence, offence and penalty in a public newspaper, at the expense of the offender.73
The MDR Rules also stipulate that any contravention may result in suspension or cancellation of a licence for enlistment or registration of medical devices, being declared guilty of an offence under the 2012 Act and conviction thereunder.74
Any contravention in relation to narcotics is punishable with imprisonment and a fine.
V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYORS
There is nothing to report.
VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS
Laws pertaining to clinical negligence and medical malpractice are underdeveloped in Pakistan and there are, as such, no special systems required to be set up under the legal framework to compensate persons injured by medicines or medical devices. The remedy would lie in tort, with a claim for damages.
VII TRANSACTIONAL AND COMPETITION ISSUES
i Competition law
Competition in all sectors is regulated by the Competition Commission of Pakistan (CCP) established pursuant to the Competition Act, 2010 (the Competition Act) and the rules and regulations framed thereunder.
Certain agreements are prohibited under Section 4 of the Competition Act, including exclusivity agreements. However, the CCP may grant individual or block exemptions.
ii Transactional issues
There are no transactional issues as such.
VIII CURRENT DEVELOPMENTS
The National Health Vision 2016–2025 serves to align Pakistan's vision and international health priorities and aims to provide a unified national direction to harmonise provincial, federal, inter-provincial and inter-sectoral efforts to achieve the desired health outcomes.
1 Arlin Merchant is an associate at Kabraji & Talibuddin.
2 This term is defined in Section 2 of the 2012 Act to include drugs, alternative medicine, medical devices and biologicals and such related products as may be notified by DRAP.
3 Messrs Azfar Laboratories Private Limited through Directors and others versus Federation of Pakistan through Secretary Ministry of National Health Services and 4 others (PLD 2018 Sindh 448).
4 The general direction, administration and monitoring of DRAP vests with the Policy Board; Section 9 of the 2012 Act.
5 Section 2 (xviii) of the 2012 Act read with Schedule I thereof.
6 Please see the Guidelines for Manufacturer/Importer of 'Food Supplement' or 'Dietary Supplement' or 'Health supplement' or Nutraceuticals and Medicated Cosmetics for what is meant by 'Pharmaceutical Dosage Forms'.
7 Rule 4 of the Research Rules.
8 Rule 6 of the Research Rules.
9 Rules 3 and 7 of the Bio-Study Rules, respectively.
10 Conduct of Clinical Trials Guidelines.
11 Rules 8 and 10 of the Bio-Study Rules.
12 Rule 8(3) of the Bio-Study Rules.
13 Rule 8(18) of the Bio-Study Rules.
14 Rule 7 of the Research Rules.
15 Rule 22 of the MDR Rules.
16 Rules 38 and 42 of the MDR Rules.
17 Section 23(2) of the 1976 Act.
18 SRO 142(I)/2018 from the Ministry of National Health Services, Regulations and Coordination dated 7 February 2018.
19 Rule 24 of the MDR Rules.
20 Drug Regulatory Authority, Priority Review and Accelerated Approval of Registration/Market Authorization, 1st Ed.
21 Section 7(1) of the 2002 Ordinance.
22 Section 31 of the 2002 Ordinance.
23 Rule 6(1) of the MDR Rules.
24 Rule 6(2) of the MDR Rules.
25 Rule 9 of the MDR Rules.
26 Rule 8 of the Alternative Medicines Rules.
27 Rule 14 of the Licensing Rules.
28 Basic manufacture is defined in the Licensing Rules as the 'manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes'.
29 The term 'semi-basic manufacture' means the 'manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking'.
30 The Licensing Rules define 'formulation' as the 'all operations involved in converting a drug into a final pharmaceutical dosage form ready for usage as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes'.
31 Repacking, in the Licensing Rules, means 'all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labelling with a view to make it ready for retail sale or wholesale, but does not include any compounding, or processing with a view to formulate it in any dosage form.'
32 Rule 4 of the Licensing Rules.
33 Rule 6 of the Licensing Rules; the application for renewal is made within 60 days of the expiry of the initial licence.
34 Rule 30 of the Licensing Rules.
35 Rule 3 of the MDR Rules.
36 Rule 3 of the Alternative Medicines Rules; an application is addressed to the Director of Division of Health and OTC Products (non-drugs).
37 Rule 3(2) of the Alternative Medicines Rules.
38 Rule 10(2) of the Alternative Medicines Rules.
39 Rule 10(3) of the Alternative Medicines Rules.
40 Section 24 of the 1976 Act.
41 Rule 31(6) of the Licensing Rules.
42 Rule 33 of the Licensing Rules.
43 Rule 35 of the Licensing Rules.
44 Rules 64 and 65 of the MDR Rules.
45 Rule 66 of the MDR Rules.
46 Rule 11 of the Alternative Medicines Rules.
47 Section 25 of the 1976 Act.
48 Rule 38 of the MDR Rules.
49 Rule 10(5) of the Alternative Medicines Rules.
50 National Essential Medicines List, 2016 - http://apps.who.int/medicinedocs/documents/s23102en/s23102en.pdf.
52 Section 23 of the 1976 Act.
53 Rules 8 and 21 of the Import Export Rules.
54 Rule 21 of the MDR Rules.
55 Rule 25 of the MDR Rules.
56 Rule 27 of the MDR Rules.
57 Rule 30 of the MDR Rules.
58 Section 2(j) of the Narcotics Act.
59 Section 2(s) of the Narcotics Act.
60 Section 2(za) read with Schedule of the Narcotics Act; entries from the list include: (1) alprazolam; (2) brolamfetamine; (3) cloraepate; (4) dexamphetamine; (5) fencamafamin; (6) flurazepam; (7) lefetamine; (8) medazepam; (9) phenobarbital; and (10) vinybital.
61 Section 6 of the Narcotics Act.
62 Section 7 of the Narcotics Act; to the best of our knowledge, no rules have been framed thus far.
63 Section 17 of the 1976 Act.
64 Section 19(6) and 19(7) of the 1976 Act.
65 Section 12(1)(a) of the 1976 Act.
66 Section 3(2) of the Pricing Policy.
67 Section 3(5) of the Pricing Policy.
68 Section 3(4) of the Pricing Policy.
69 Section 29 of the 1976 Act.
70 Section 41 of the 1976 Act.
71 Section 42 of the 1976 Act.
72 Section 34 of the 1976 Act.
73 Section 35 of the 1976 Act.
74 Rule 46(2) of the MDR Rules.