2. Introduction to Good Regulatory
Good Regulatory Practices (GRP) are internationally
recognized processses, systems , tools and methods
for improving the quality of regulations.
GRP systemtically implements public consultation
and stakeholder engagement as well as impact
analysis of government proposals, before they are
implemented to make sure they are fit for purpose
and will deliver what they are set out to achieve.
• Regulation of medical products for human use.
• Intended for multiple audiences-
• Senior policy-makers responsible for the
formulation of health policies , laws, regulations.
• Regulatory Authorities.
• Parties affected by or interested in regulatory
• Equally relevant to eastablishing new regualatory
systems and existing ones.
• Does not explicity cover development of laws.
• Licensing is the transfer of rights to a third party
(the licensee) to use the intellectual Property
Owned by an innovator (the Licensor) under
mutually agreed terms and conditions. Licensing
can be for manufacturing and or marketing rights
in select geographs, renewable after the initially
agree period. This intelletual property offered by
Licensor (Innovator) can be one of the following :
• A patent covering a product or process
• The right to use of a trademark or brand name
• Copyright of process/technology
• The national e-Governace plan (NeGP) was
launched in 2006 as an initiative that the
Government of India has implemented to make all
the government services accessible online. It has
been activated in all the government departments
with a vision to transform India into a digitally
empowered society and knowledge economy. In
this process , numerous policy have been amended
to facilitate the growth of the pharmaceutical
industry in India under the ministry of Health and
Family Welfare (MoHFW). The central Drugs
standard Control Organization (CDSCO) and Drug
Controller General of India (DCGI) play a vital role
6. • Import and Export of HUman Biological Samples
Without Priror Approvals.
• In August , one of the first such guidelines for
biological sample was published by the Central
Drug Standard Control Organization (CDSCO). No
licenses are needed prior to import or export of
Human Biological Samples . A self-sertified
statement needs to be sent to the Customs
department stating that all rules and guidelines are
being followed. The department will reply wit its
approval for the same and import/export can occur
7. • No permission needed for Clinical Trials intended
for Academic Purposes. No prior approval is
required for conducting clinical trials that are
intended for academic purposes.
• This is with respect to an approved drug
formulation for any new indication or new route of
administration or new dosage.
• The trial shall be approved by the Ethics Committee
and the data created is not intended for
submission to the licensing authority.
• The ethics committee shall inform the licensing
8. • Hence, it shall be presumed that no permission
from the licensing authority is required.
• 3. Quality Management System for Notified
Medical Devices and In vitro Diagnostics.
• As per the Gazette of India , the quality policy for
notified medical devices and in vitro diagnostics
must be obliged by the top management of the
manufacturer shall :
• Ensure that the quality objectives are met at all
levels of the corganization
• Plan thequality management system in order to
9. Requirement of 50 bedded site
for clinical trials.
• In the past , there have been certain inssues on the
conduct of clinical trials in India. In the meetings
held on 20.08.2015 and 6.10.2015 resectively
under the chairmanship of secretary, Ministry of
Health and Family Welfare (MoHFW) in which
experts including the secretary , D/o Health
Research and Director General , Indian Council of
Medical Research (ICMR) and Director General
Health Services were present. It was concluded that
10. • No clinical trials will be conducted at a hospital site
of less than 50 beds.
• The ethics committee shall assess the need and
decide whether the clinical site is suitable for the
trial or not , irrespective of the number of beds.
• In addition , all sites where clinical trials are
conducted shall have an emergency rescue and
care management system along with all other
necessary facilities required for that particular
• No NOC (No objection certificate) required for
11. Investigator can take up more
than three Clinical Trials.
• As per the meetings held on 20.8.2015,
respectively under the chairmanship of Secretary,
D/o Health Research and Director general , Indian
Council of Medical Research (ICMR) and Director
General Health Services were present the following
were decided :
• The restriction of three clinical trials prior per
investigator has been removed.
• The ethics committte after examining the risk and
complexity involved in the trial being cnducted,
shall decide about how many trials an investigator
12. SUGAM Portal.
• CDSCO, in order to implement e-governance in its
offices, has launched the SUGAM portal on
14.11.2015 . It is intended for :
• Filing Applications for the import and registration of
drugs and medical devices.
• Now the service is being extended to the online
submission of applications for the grant of NOC for
BA/BE studies for export purpose.
• Moreover , applicants seeking NOC for BA/BE
studies for the export purpose should register them
and apply only before the deadline.
13. Commuity Pharmacy
• Definition .
• Community Pharmacy means any place under the
direct supervision of a pharmacist where the
practice of pharmacy occurs or where prescription
orders are compounded and dispended other than
a hospital pharmacy or limited service pharmacy.
• Scope of community pharmacy.
• Community Pharmacy has a large number of scopes
or approaches , which are related to patient
couenseling and patient drug control.
14. Good Pharmacy Practice
• Good pharmacy practice requires that a
pharmacist's concern must be the welfare of the
patients in all settings.
• Good pharmacy practice requires that the core of
the pharmacy activity is the supply of medication
and other health care products , of assured quality ,
appropriate information and advice for the patient
and monitoring the effects of their use.
• Good Pharmacy practice requires that an integral
part of the pharmacist's contribution is the
promotion of rational and econmic prescribing and
appropriate medicine use.
15. • Good Pharmacy Practice requires that objective o
each element of pharmacy service is relevant to the
individual , is clearly defined and is effectively
communicated to all those involved.
• Hospital Pharmacy :The practice of pharmacy
within the hospital under the supervision of a
professional pharmacist is known as hospital
16. Functions of Hopital Pharmacy.
• Dispensing of drugs chemicals and pharmaceutucal
preparation in hospital.
• Preparation and sterilization of injectable drug if
prepared in hospital.
• Necessay inspection of all pharmaceutical supplies
in other department of hospital.
• Maintenance of an approved stock of antidotes and
other emergency drugs in hospital.
• Maintenance of records of dispensing of all narcotic
drugs and alcohol in hospital.
• Maintenance of records and specification of
17. Personnel requirements for
• The hospital pharmacy is integrated with the
dispensing section , manufacturing section , quality
assurance section and clinical pharmacy services.
The requirement of personnel for an inpatient
pharmacy depends on the nature and quantum of
services provided by the department . The
requirement of hospital pharmacists in hospitals is
based on workload and number of beds in hospital.
• Generally , small hospitals require a minimum of
three pharmacists, but this varies with the number
of beds in each hospital.
18. Pharma Manufacturing.
• Pharma manufacturing refers to the industrial scale synthesis of
pharmaceutical drugs. This is a process with many challenges and
techniques that practitioners will need to be aware of to ensure
that drug development is optimized. Numerous methods and
tools can be applied to enhance manufacturing optimization
• The pharmaceutical industry includes the manufacturer ,
extraction , processing , purification and packaging of chemical
materials to be used as medications for humans or animals.
• Pharmaceutical manufacturing is divided into two major stages :
the production of the active ingredient or drug (primary
processing or manufacture) and secondary processing , the
conversion of the active drugs into products suitable for
administration. This document deals with the synthesis of the
active ingredients and their usage in drug formulations to deliver
the prescribed dosage. Formulation is also referred to as galenical
19. • The main pharmaceutical groups manufactured
• Propriatery ethical products or prescription only
medicines (POM) which are usually patented
• General ethical products , which are basically
standard prescription-only medicines made to a
recognized formula that may be specified in
standard industry reference books.
• over the counter (OTC) or nonprescription ,
20. • The products are available as tablets, capsules ,
liquids in the form of solutions , suspensions ,
emulsions , gels or injectables, creams usually oil-
in-water emulsions, ointments usually water in oil
emulsions and aerosols that contains inhalable
products or products suitable for external use.
Propellants used in aerosols include
chlorofluorocarbons (CFCs) which are being phased
out . Recently , butane has been used as propellant
in externally applied products.
21. Wholesale Business.
• The function of pharmaceutical wholesalers is to act as
an intermediary between the pharmaceutical industry
and their customers (e.g. hospital and community
pharmacies) by purchasing and distributing medicines
to their customers. With regard to pateint safety they
must guaranty that the quality of the products is kept
through the whole distribution line and that the influx
of counterfeited drugs is avoided. To meet this demand
wholesalers have developed sophisticated distribution
• Recent experience from counterfeit cases
demonstrated that the wholesalers may play an
important role in protecting the drug market from
22. Regulations of the distribution of
• 1. National legislation should be in place to regulate the
activities of persons or entities involved in the
distribution of pharmaceutical products.
• 2. The distributor or the organization to which the
distributor belongs should be an entity that is
appropriately authorized in terms of applicable legislation
to perform the functions that it intends to perform. The
distributor or the organization to which it belongs should
be held accountable for the activities that it performs
which relates to the distribution of pharmaceutical
• Only persons or entities which are authorized to do so or
which hold the appropriate license should be entitled to
import or export pharmaceutical products.
23. • Distributors or their agents may only distribute a
pharmaceutical product within or to a country or territory if a
marketing authorization or similar authorization has been
granted, that allows the use of that pharmaceutical product in
that country or territory .
• Holders of an authorization to distribute pharmaceutical
products should obtain their supplies of pharmaceutical
products only from persons or entities which are in possession
of the applicable authorization to sell or supply such products
to a distributor .
• Distributors or their agents should supply pharmaceutical
products only to persons or entities which are themselves
authorized to acquire such products either in terms of an
authorization to act as a distributor or to sell or supply
products directly to a patient or to his or her agent.
24. • Some duties and responsibilities may be delegated or
contracted out to suitably desigated persons or entities as
authorized and as necessary . Duties and responsibilities
should be specified in a written agreement. There should be
no gaps or unexplained overlaps with regard to the
application of GDP. These should be a periodic audit of such
activities with regard to application of GDP.
• If a distributor or his or her agent subcontracts an activity to
another entity, the person or entity to which the activity is
subcontracted must be appropriately authorized to perform
the subcontracted activity and should uphold the same
standards as the distributor.
• The sale of pharmaceutical products via the Internet should
be limited to registered and authorized mail-order
pharmacies or other authorized entities.
25. Import , Export of Drugs and
• Medical devices are usually mechanical in nature and
developed based on bioedical engineering to
permanently or temporarily replace a function of the
body . It ranges from simple and everyday consumer
products such as spectacles, bandages and plasters to
supplies such as gloves and syringes to implants , stents
and X-Ray equipment.
• Medical Devices have shorter product life cycle and
investment recovery period (typically 18-24 months on
the market) due to the high rate of innovation.
Improvements of mdical devices can be continuous
process, as they often result from the feedback
received from the clinicians and users and can be
shared with the product engineer to improve design
and best practices.
26. • The effectiveness of medical devices is dependable
on external factors such as the skills and experience
of the physician , the quality of the hospital and
how the users utilise it . It can give healthcare
professionals a competitive edge as people usually
visit a particular hospital odoctor for their skills
and experiences even if the practice next door
possesses the same devices.
27. Regulations of Devices.
• The approach to quality of devices depends largely on regulation.
In addition , there are many problems in the interface between
the machine and the user or the patient that are largely
untouched by device regulation and cinsidered in quality
assurance programs. As essential as device regulation is , it is not
sufficient to assure quality .Education is particularly important in
this area. Quality assurance programes need to familiar with
common problems with medical devices and how to approach
• The regulation of medical devices is a vast and rapidly evolving
field that is complicated by legal technicalities. For example, legal
terms and their meanings are sometimes non-uniform even
within one regulatory system. Optimum safety and performance
require among all involved in the life span of a medical device ,
the government , the manufacturer, the importer /vendor , the
user and the public each has a specific role to play in this risk
28. • Each question carries two marks.
• 1. What is Good Regulatory Practices?
• 2. Give the score of Good Regulatory Practices?
• 3. Define community Pharmacy .
• 4. Define Hospital Pharmacy.
• Each qustion carries 10 marks.
• 1. Write a note on amendment of the policies made
by CDSCO and DCGI.
• 2. Write a note on Pharma maufacturing and
wholesale business of pharmaceutical products.
29. • 1. The national e-Governance plan (NeGP) was
lauched in -
• a. 2006 b.2007 c.2008 d. 2009
• 2. The first guidelines for import or export of
human Biological Samples was published by .....
• a. ASHP b. CDSCO c. GDP d. None.
• 3. .......is internationally recognized processes,
systems , tools and methods for improving the
quality of regulations.
• a. GDP b.GLP c.GRP d. CDSCO
• 4. ..........is defined as actual practice of pharmacy