In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945 (hereinafter refer as Act) made there under. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of drug (Section 3b of the Act) required to be registered before import into the country.

Not only drug but the manufacturing site needs to be registered for import. If the drugs, fall within the definition of New Drug (Rule 122 E of the Act), the new drug approval is the pre-requisite for submission of application for Registration and or import of drug.

The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturers‘ having a whole sale License in the country.

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Good Clinical Practice is a set of guidelines for biomedical studies that encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects.

The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented.

The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and the authenticity of biomedical data generated.

This guideline having seven parts:

  1. Definitions
  2. Pre-requisites for the study
  3. Responsibilities
  4. Record Keeping and Data Handling
  5. Quality Assurance
  6. Statistics
  7. Special Concerns
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The Biopharmaceutics Classification System (BCS) is a scientific framework that is based on the aqueous solubility and intestinal permeability of the drug substance. It classifies the drug substance / active pharmaceutical ingredient (API) into four classes as below:

  • Class 1: High Solubility – High Permeability
  • Class 2: Low Solubility – High Permeability
  • Class 3: High Solubility – Low Permeability
  • Class 4: Low Solubility – Low Permeability
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This guideline specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action.

This guideline contains the following points;

  1. Introduction
  2. Scope
  3. Main Guideline Text
  4. Definitions
  5. Appendix I Dissolution Testing and Similarity of Dissolution Profiles
  6. Appendix II Bioequivalence Study Requirements For Different Dosage Form
  7. Appendix III BCS-Based Biowaiver
  8. Appendix IV ASEAN Bioequivalence Study Reporting Format
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The guide is established to facilitate and provide guidance to organisations in setting up a manufacturing facility for medicine-based biological products in Malaysia, including cell and tissue products, blood/plasma-derived products and biotechnology products. It is also a guide for a laboratory/manufacturing facility to obtain Good Manufacturing Practice (GMP) status from National Pharmaceutical Regulatory Division (NPRA).

This guideline describes the following points;

  • Guidelines in Use
  • Regulatory Process Description
  • Department/ Person-In-Charge
  • Related Authorities
  • Frequently Asked Questions (FAQs)
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The primary objective of CGTP regulation is to safeguard public health and patient safety. CGTPs should meet the same stringent standards on quality, safety and efficacy, as of any other biological products. In regulating CGTPs, we undertake a cautious science-based approach balanced against mitigating unnecessary administrative costs to the product developer

This multidisciplinary guideline will address development, manufacturing and quality control as well as nonclinical and clinical development of CGTPs which include somatic cell therapy, tissue engineering and gene therapy products as defined in this document. This guideline is intended for products entering the registration process at NPCB.

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Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality includes Not of Standard Quality, Adulterated or Spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the Provisions of Drugs & Cosmetics Act and also those products for which product licenses are suspended/cancelled.

Rapid Alert System is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. Assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or harm to animals (in case of veterinary product), consumers, operators and the environment.

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Throughout the registration validity period of a natural (traditional medicine & homeopathy) and health supplement product, the product registration holder is responsible for the product that is placed in the market and to make any amendments to the registration dossier based on any technical and scientific progress regarding the product. This is required to enable the natural and health supplement products to be manufactured and evaluated by generally accepted scientific methods. Such amendments have to be approved by National Pharmaceutical Control Bureau (NPCB).

This guideline is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a natural and health supplement product of abridged category. It is not applicable for natural and health supplement product of full evaluation category and reference shall be made to Malaysian Variation Guideline for Pharmaceutical Product instead. Variation applications are categorized into Major Variation, Minor Variation (Prior Approval) and Minor Variation (Notification). The guideline covers variation on both drug product (finished product) and drug substance (active ingredient). Updating of this guideline will be done on a periodic basis as required.

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A biologic product will undergo various manufacturing process changes and updates to their product labelling throughout its lifetime. The changes will be inevitable and are often implemented regularly. Reason of changes would include (but not limited to):
a. To maintain the routine production (e.g replenishment of cell banks, seed lots, and reference standard)
b. To improve the quality attributed or the efficiency of the product (e.g changes in the manufacturing process, equipment of facility)
c. To update product labelling information (e.g to add/edit indication and/or to improve the management of risk by adding a warning, limiting the target population, changing the dosage regimen and adding information on co-administration with other medicinal products)

This document provides guidance for manufacturers and the product registration holders (PRH) on the conditions and supporting documents for a variation application of registered biologic products.

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Distribution is an important activity in the integrated supply-chain management. With the globalization of the pharmaceutical industry, various individuals and organisations from locations around the world are generally responsible for handling, storage and distribution of such products. Therefore it is important to have adequate control over the entire supply chain from manufacture to delivery to the patient or end user. This guideline lays down the appropriate principles for those involved in the supply chain in conducting their activities while ensuring the maintenance of high standards of quality assurance and integrity of the distribution processes. Not all of the principles described will be relevant to every situation as it is recognized not all the principles are applicable to certain companies or environment. The principles should be adapted to meet individual company’s needs where necessary. Alternative practices to those set out in the guideline that achieve an equivalent or better outcome can be adopted by companies provided that such alternative practices can be shown or demonstrated to achieve an outcome that is equivalent to or better than the provisions in the guideline. When the distribution chain is interrupted by manufacturing steps such as repackaging or relabeling, the principles of Good Manufacturing Practice (GMP) should be applied to these processes.

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