Medicines registration & licensing of pharmaceutical establishments of Nepal
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This document discusses medicines registration and licensing of pharmaceutical establishments according to Nepal's Drugs Registration Rules, 2038. It outlines the legal framework and institutional setup, including requirements to obtain recommendation letters from the Drug Development Agency to establish a drug industry or for export/import, as well as licenses needed for manufacturing and marketing drugs. It notes some areas for improvement, such as clarifying procedures, setting time limits, separating registration by drug type, reducing duplicate registration efforts, and simplifying the registration process through online facilities.
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Business Overview
Overview of business
INDEX
Types Of Business
Industrial Sector
Globalization
Definition:
Business is an economic activity involving the regular production or distribution of goods and services with the objective of earning profits through the satisfaction of human wants.
Types of business:
1.Service
2.Manufacturing
3.Trade
Service
Service industry is the major type of business running in India. Examples – entertainment, consultancy, banking, telecommunication, call centres, KPO, etc.Service is different from manufacturing and trading of goods.
Manufacturing
In manufacturing, the items are produced using raw materials with the help of different engineering process and technologies. Other business depend on manufacturing. Hence it is very important. Example- machines, automobiles, stationary, etc.
Trade
These enterprises are concerned with the distribution of products i.e. sale of products , distribution, transfer, exchange of goods to business houses as well as consumers. Trading enterprises may be found operating in form of :
Wholesale
Retail
Import and export
Investment trusts, etc.
Types Of Industrial Sector
Trade
Automobile
Cement
Chemicals
Pharmaceuticals
Engineering goods
Jute
Iron and steel
Village industries
Petrochemical
Rubber & leather products
Small scale industries
Sugar
Tea
Textile
Agro based
Food based
Handicrafts, etc.
Engineering Industry
Engineering industry mainly deals with:
Design
Manufacture
Operations of structures, machines, or devices.
This industry primarily includes sectors like:
Civil
Computer and IT
Industrial
Electrical
Mechanical
Chemical
Process Industry
The process industries do different processes on the raw material to produce the final product.
The process could be either continuous or occur on a batch of materials.
Examples:
Wood and wooden products
Chemicals
Paper
Textile
Coal
Rubber
Plastics, etc.
Textile Industry
Textile industry deals with design and manufacturing of clothing products. Indian textile industries are one of the leading in the world. It includes following sectors:
Cotton
Jute
Sericulture
Wool and woollen
Man made fibre/ filament yarn
IT Industry
Information technology (IT) industry in India has played a key role in putting India on the global map. IT industry in India has been one of the most significant growth contributors for the Indian economy.
Major IT companies are:
Infosys
Accenture
Cognizant
CMC
Wipro
Oracle, etc.
Globalization
Globalization (or globalisation) is the process of international integration arising from the interchange of world views, products, ideas and other aspects of culture.
Globalization has allowed companies to increase their base of operations. It has supported companies to expand their workspace with relatively small investments and provide novel services to a wide range of consumers.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
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Pharmaceutical Licensing
There has been an increase in R&D spending but a decline in research productivity, potentially leaving drug developers with insufficient pipelines. Mergers and acquisitions have aimed to strengthen pipelines and gain scale but larger companies now focus on blockbuster drugs. Licensing has become a major source of new products for large pharmaceutical companies and deals are occurring earlier in development stages.
LICENSING & FRANCHISING
Franchising is a business model where a parent company allows entrepreneurs to use its strategies, trademarks, and system in exchange for an initial fee and royalties. The parent company provides support including advertising and training. It is a cheaper way for the parent company to expand than opening its own stores. The franchising business model consists of franchisors who license their brand and franchisees who operate locations using the franchisor's system.
Drugs & cosmetics act 1940
(i) Not below the rank of Deputy Drugs Controller
(ii) Qualification as prescribed for licensing authority
Functions:
(i) Grant/renewal/suspension/cancellation of licences
(ii) Inspection of premises
(iii) Collection of samples
(iv) Prosecution of offenders
SJTPC 25
Controlling authority
Qualification:
(i) Graduate in Pharmacy or Pharmaceutical
Chemistry or Medicine with specialization in
clinical pharmacology or microbiology
Functions:
(i) Co-ordination and unification of the activities of all
licensing authorities under it.
(ii) Appellate authority against the orders
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Medicines registration & licensing of pharmaceutical establishments of Nepal
- 1. Medicines registration & licensing of pharmaceutical BY: establishments AMI T SHRESTHA BHASKAR SHRESTHA RAJAN GHIMIRE SAJAN MAHARJAN SUMAN KUNWAR
- 2. Legal framework & Institutional set-up “Drugs Registration Rules, 2038“ To establish drug industry: Recommendation letter to be obtained from DDA (Chapter 4 Section 7) Product Registration Product license to be obtained to manufacture drug (Manufacturing License) (Chapter 4 Section 8) Registration of drug prior to sale and distribution (Marketing License) (Chapter 4 Section 8A) Exportation or importation of drug Recommendation letter to be obtained from DDA (Chapter 4 Section 9) Validity period and renewal of product license, recommendation letter and certificate (Chapter 4 and Section 11). Fee for all above is given by Schedule 14.
- 3. Improvements + Outcomes Where and whom should we consider during registration is not clearly mentioned. There should be clear information about where and whom should we consider during the process Clarity of Rules and Less confusion to people No time limit for recommendation letter, license or any work process Time limit for certain work process or licensing should be specified Enhance working efficiency and Save time
- 4. Different section for each group of medicine and separate registration book for each type should be available (New drugs, Biological products, Aurvedic products, Veterinary and so on) Ease in Handling registration works Less time consuming as works will be distributed Same product registration is done twice Mfg licence can be given to a group of drugs to be manufactured in same area and marketing licence can be given to individual drug Reduce registration cost hence more product registration possible
- 5. For each product registration, manufacturer should go to DDA Simplify the product registration process via online registration facilities Saving of time, cost and labour