Profit margin in Pharmaceutical Sector (Manufacturer to Retailers)

Profit margin in pharmaceutical business: Retailers: 16-22% Distributors: 8-12% Stockist: 6-10% CFA: 4-8% Company: Vary according to marketing type


I am a 3rd year B. Pharm student and want to know about What are the profit margins of a pharma business? Kindly Explain in a particular cycle i.e. Profit from a manufacturing company to retailer?


Profit margin in pharmaceutical business vary company to company. We can’t estimate any company’s margin just by analyzing from outside. We have to involve deeply with company business strategy to calculate the margin in pharmaceutical sector. Profit Margin of chemists, pharmacies, stockists  and Carrying and Forwarding agent (CFA) also vary depend upon many factors like branded medicine, generic medicines, brand value of medicines, otc product, company status, ethical/unethical practice etc.

Here we are going to explain a general profit margin cycle from manufacturer to retailers. First you need to know about distribution channel in pharmaceutical sector through which profit share divides. A distribution channel includes mainly following parts:

  • Company (Manufacturing and/or Marketing Company)
  • Carrying and Forwarding Agent
  • Stockist
  • Distributor
  • Retail/Chemist/Pharmacy

Profit margin should be divide between above five firms/individuals. But actually profit margin will be distributed in another individuals also. That we will discuss later in article. First we start from bottom side. The reason from starting bottom side is that their margins are some what fixed if profit margin is taken ethically.

In case of unethical practice, profit margin may be many times greater than actual profit margins. Unethical practice means selling a medicines by much higher than its actual cost after adding own profit e.g. selling generic medicines at MRP (Maximum Retail Price) but in actual its cost is 4-5 times less than MRP.

Company’s margin vary according to its expenses. A company will handle a big sales team, executives, staff members, workers etc. Company has to invest at stock, machinery, plant, advertisement, promotion and other aspects. How much bigger their expenses, they have to set profit margins accordingly. Sale turnover also affect profit margin.

Bigger sale turnover will provide bigger profit so company can compete in market by taking low margins. Competitors also play role in mrp, trade rates fixation hence profit margins. Many factor affects the profit margin of a company.

Nothing is fixed in pharmaceutical sector. Below margin’s explanation is based upon standards margins. These can be vary as we discussed above and according to company marketing type like branded marketing, generic marketing, franchise marketing, pcd marketing etc.

A retailer/Pharmacy margin is approx. 16-22% percent ethically. Along with margins they also get benefits of scheme and offers provided by companies. Retailers/pharmacies also enjoy credit facilities provided by companies and/or stockists.

A Distributor margin is approx. 8-12%. Distributors could also enjoy some benefits scheme and offers. At distributor level credit facility could be enjoyed.

A Stockist margin is approx. 6-10%. At stockist level  less chances of scheme/offers. Majority of cases a stockist has to invest many in distribution channel by providing advance payment to company/CFA and/or credit facility to distributors.

Carrying and Forwarding Agent (CFA) margin is approx. 4-8%. CFA plays middle man role in majority of cases. They receive stock from company in bulk and distributes it to stockists in small quantity.

Company profit margin is difficult to fix and/or calculate. Many factors affect profit margin fixation. At pharmacy, stockist, distributor and cfa level, there is fixed expenses and running cost. Hence fixed margins don’t affect their money circulation.

But at Company hand lot of things to consider. As we discussed above company profit margin depend at many factors. What could be the possible profit margin that we will understand with a simple example according to their marketing types.

  • Branded Marketing Type Company
  • Generic Marketing Type Company
  • Franchise/Pcd Marketing Type Company
  • Over The Counter (OTC) Marketing Type Company

Suppose a Medicine’s cost after adding all manufacturing expenses* is 30 Rs. Now margin in each type of marketing will be different.

In Branded marketing type, profit margin will be calculated after adding all sales and marketing expenses like Sales Team Salary/Tour Expenses, Doctor’s expenses*, transportation, office staff salary and expenses, promotional expenses and related expenses.

Practically all these expenses cost could not been added in any single product but expenses calculation verses profit margin is based upon all products included in company’s product list.

In Generic Marketing Type, company don’t spend at sales team, doctors etc. Company Fixed a particular margin like 5%, 10%, 20%, 30% etc and dispatch to CFA and/or Stockist. Now their turn how they distribute it at how much profit margin.

In Franchise/Pcd Marketing Type, Company do the same as in Generic marketing Type and fix a particular margin and dispatch goods to CFA and/or Stockist. But in Franchise/Pcd marketing , stockis/CFA has to calculate their profit margin based upon factors we discussed in Branded marketing type like sales team salary/tour expenses, doctor’s expenses, transportation etc.

In Over The Counter Marketing (OTC) Type, company fixed its margin based upon factors like advertisement expenses, sales team salary/tour expenses, transportation, promotion expenses and other related expenses etc.

Above we have discussed about marketing type. That will be applicable for both pharmaceutical marketing company and pharmaceutical manufacturing company when they will sell and/or market their products. Now we will try to find out profit margin of a Pharmaceutical Manufacturing unit/company at manufacturing end.

Pharmaceutical Manufacturing unit get profits by two ways: By Own Marketing and/or By Third Party/Contract Manufacturing/Loan Licensing. By Own Marketing profit margin will be calculated as we discussed above in Marketing type.

Manufacturing companies who reliable at third party/contract manufacturing calculate their margin depend upon batch size, cost of raw material, plant capacity etc. Generally 25-40% margin is added by manufacturing unit at their cost sheet of third party/contract manufacturing rates.

Loan License manufacturing profit margin is different from above mentioned details. In loan license, a manufacturing unit is hired/rented by loan licensee. Loan licensee can manufacture own product at manufacturing unit by own self. Generally rent and manufacturing process expenses is given by loan licensee to manufacturing unit.

Same Profit margin is applicable for Ayurvedic, Food and Dietary Supplements and Cosmetic Industry

Hope this article will be helpful for you to know about profit margin in Pharmaceutical Sector.

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Renewal Omitted: No Need for Renewal of Pharmaceutical Drug Licences and its Effect

With effect from new amendment in Drug and Cosmetic Act, 1945, you will not need for renewal of your drug license in future. If you have Retail/Pharmacy, Wholesale/Distribution, Loan or Manufacturing License Form* for pharmaceutical and cosmetic preparations then you will have no need to renew it.

You only need to deposit license retention fee before expiring of a period of every succeeding five years from date of issue of its issue, unless it is suspended or cancelled by licensing authority.

In case Licencee failed to deposit this fees at due time, then licencee shall be liable to pay licence retention fee along with a late fee calculated at the rate of two percent. In case of of non payment till six month, License shall be deemed to have been cancelled.

This amendment will be beneficial for all pharma business correspondents. It was tricky process to renew drug license. One has to follow complete process as in case of new license.

Now this amendment will provide relief to all manufacturing, wholesale and retail licencee whose licence were due this year and in future.

But few rules also been added through this amendment. Now your premises will be inspected by drug inspector at compulsory basis for minimum of one time in three year. Maximum number of inspection could be as needed as per risked based approach.

More rule is added in the provision.

For Retail and Wholesale: – Inspection for verification of compliance:  “The licensing authority shall cause inspection, by the Inspector  appointed under the Act, of each premises licensed under this Part, to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.”

For Manufacturing and Loan Licensing:-  Inspection for grant of licence and verification of compliance.-

“(1) Before a licence in Form —–* is granted, the licensing authority shall cause the establishment in which the manufacture of drugs is proposed to be conducted or being conducted to be inspected jointly by the Drugs Inspectors appointed by the Central Government and the State Government under this Act who shall examine the establishment intended to be used or being used for the manufacture of drugs.

(2) The premises licensed under sub-rule (1) shall be inspected jointly by Inspector appointed by the Central Government and State Government to verify the compliance with the conditions of licence and the provisions of the Act and these rules not less than once in three years or as needed as per risk based approach.”

Same rules will also be applicable for manufacturing and loan licensing of cosmetic and Homeopathy products.

Effect of omitting Renewal at Pharmaceutical Sector:

  1. Renewal was a time consuming process. This will prevent time consumed during this process.
  2. It will build transparency in drug license process.
  3. Work Overload of drug department will be less. Now Drug Department can concentrate at proper implementation of laws and rules according to Drug and Cosmetic Act.
  4. Inspection will be compulsory. It will forced licencee to fulfill all requirements as drug department may conduct inspection at regular basis.
  5.  This amendment is focus at implementing good manufacturing standards as new plants will be inspected by Joint team of Center and State Drug Authority.
  6. Quality of Products manufactured in India may improve as manufacturing standard compliance could be regularly checked.
  7. More control of Drug Authorities will be at ground level for maintaining standards and availability of quality products.

* Form:

Form 19, Form 19A, Form 19AA and Form 19C, Forms 20, 20A, 20B, 20BB, 21C, 21CC, 20F, 20G, 21, 21A, 21B or Form 21BB,  Form 24, Form 24A, Form 24B, Form 24C, Form 24F, Form 25 or Form 25A or Form 25B or Form 25F, Form 26, Form 26A, Form 26B, Form 26F, Form 26H, Form 27, Form 27A, Form 27B, Form 27D, Form 27DA, Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA, Form 31 and Form 31A, Form 32 or Form 32A, Form 33, Form 33, Form 33A, Form 37 and Form 38. Know more about form Read our Article: Types of Licences required to start business in Pharmaceutical Sector

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New Pharma Policy: Would Third Party/Contract Manufacturing be Banned?

As per news circulated through out web, news paper and tv, third party/ contract manufacturing is going to be banned. But we are not sure about source of these news and whether these are true or not. If these are true, then it will not be beneficial for pharmaceutical sector. A large number of manufacturing units and thousands of marketing companies have shut down. This will be great loss to pharmaceutical sector and ultimately medicines will be costlier due to monopoly of few pharmaceutical countries. 

We received queries in this regard from many readers, so we decide to analysis few facts about these news. We will try to find out whether these romours are true or false. Here we are going to discuss about fact which will be change for third party or contract manufacturing. We don’t think, third party or/and contract manufacturing is going to be banned because it is legal phenomena and helpful in growth & new business possibilities. If we study today’s big player in pharmaceutical sector, they started as marketing company. Later they established or overtake manufacturing units. Establishing Marketing Company is much easier than to start a manufacturing unit. If government bans third party/contract manufacturing, then it will effect adversely at pharmaceutical sector growth and will increase unemployment.

Here look at possibilities that would be covered by New Pharma Policy:

In 2006, Draft National Pharmaceutical Policy, Heading Control on Pharmaceutical brands describe a very serious issue. This is what that should have resolved many years ago. This issue was related to brand name resemblance and same brand name for different preparations. For example, We have a Brand Name  Cef for an active ingredient Cefixime and another company is using Cef for an active ingredient Cefpodoxime. Same brand name is using for different active ingredients. 

In second case, Company A and Company B, both are using same Brand Name PAR for paracetamol. This create confusion and lead to misbranding. We have taken a example of only two companies, there are many cases where same brand name is using by number of pharmaceutical companies.  These type of activities have the potential to cause immense harm through mis-prescription and/or wrong dispensing. (We use brand name for sample purpose without checking whether they belong to any company or not. In case these belong to any company, please mail us at for correction)
In India there is no appropriate system to rectify these errors, so it was suggested that “branding of drugs and other therapeutics should be brought under the Central drug regulatory system. The drug regulator must be required to maintain a data base on brands and their compositions, and all brand registration of drugs must compulsorily be approved by the drug regulator. In particular, no change should be permitted in the composition of a given brand. Necessary changes would be made in the Drugs & Cosmetics Act, 1940 in this regard.”

Read Related: What would be Trade Margin if government fix margin for Pharmaceutical Products?

Few years back, manufacturing companies got approval with Brand Name, Generic Name and Marketed by companies Name from state drug department which was not a desirable practice when marketing is done at the national level. State authorities wasn’t check for brand name already approved/applied within state and/or approved/applied in other states. So, these types of approvals were stopped and approval from generic names were started to manufacturing companies. Once a generic approval was given to a manufacturing company, it was allowed to manufacture any number of brands with single generic approval. It worsen the condition because drug authorities don’t have any control of manufacturing from Brand Names.

 At present present, manufacturing companies get approval by generic name. So drug department don’t have any control at third/contract party manufacturing and brand name fixed by manufacturing and marketing companies. Brand Name registration is at present come under Intellectual property act only and Intellectual property doesn’t cover composition or active ingredients or any technical detail.  Possibility is there government want to regularized third party manufacturing. Draft National pharmaceutical policy, 2006 suggested to transfer brand name approval to central drug regulatory system. But minimum chances of banning third party manufacturing

As per our analysis, it would be compulsory to take brand approval from central drug regulatory by manufacturing or/and marketing company before launching a new product in market other than generic approval by state authorities. Without that no marketing or/and manufacturing company shouldn’t market a product in Indian market. Brand name approval should be compulsory from central drug regulatory whether a manufacturing company has generic approval from state authorities. It will helpful in controlling brand name conflicts as all approvals will be made from single authorities and all records will be maintained. Banning of third party or/and contract manufacturing is not a solution.

One another hot issue of new drug policy is related to labeling of single active ingredient preparations. It is suggested that all single salt preparations should have only generic name, not brand name. Many developing countries have adopted this label pattern along with many developed countries. In India if this implements, it should be welcomed by pharmaceutical industry. If that happens, A single active ingredient will be like a classical preparation in ayurvedic medicines. A well known Ayurvedic Classical Preparation “Ashokarishta”. We find only company logo like Dabar, Zandu, Elzac etc and Name will be same as Ashokarishta. Likewise only Logo in single pharmaceutical active ingredient preparation would be allowed and salt name will be same below logo.

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WHO Good manufacturing practices for pharmaceutical products

GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.

Under WHO-GMP: 

1. All manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications; 
2. Qualification and validation are performed; 
3. All necessary resources are provided, including: 
  • sufficient and appropriately qualified and trained personnel, 
  • adequate premises and space, 
  • suitable equipment and services, 
  • appropriate materials, containers and labels, 
  • approved procedures and instructions, 
  • suitable storage and transport, 
  • adequate personnel, laboratories and equipment for in-process controls; 
4. Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided; 
5. Procedures are carried out correctly and personnel are trained to do so; 
6. Records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is implemented; 
7. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; 
8. The proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practices (GDP); 
9. A system is available to recall any batch of product from sale or supply; 
10. Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence
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Top Five Indian Pharmaceutical Manufacturers in United States Pharmaceutical Market

India is the one of the biggest supplier of generic medicines to USA. India and USA are strong relationship while we talk about pharmaceutical and healthcare sector. India is second largest supplier of generic medicines to USA where as USA add 40 percent in total revenue of top four Indian Pharmaceutical manufacturers.

In recent time, due to change of US import policy has impacted Indian Pharmaceutical Exporter to USA. US administration’s policy of reducing import has created trouble for these exporters. Although these manufacturers have their own plants in USA but there major revenue portion come from importing medicines from India. After change in import policy of USA, Indian Pharmaceutical Companies has to change its policies and has to increased acquisition and merger of USA Pharmaceutical Companies or setting-up more manufacturing facilities in USA to keep their presence into US pharmaceutical Market.

Top Five Indian Pharmaceutical Manufacturers who has their own plants in USA:

1. Sun Pharma
Sun Pharma is 4th largest Speciality Generic Pharmaceutical Company in world having its operation in More than 150 countries and 5 continents. Sun Pharma is also largest Indian Pharma Company in the US. The Company was established by Dilip Shangvi in 1983. The company has strong presence into American Generic Market and has become Brand in US. Sun Pharma has 45 (API and Finished Goods) manufacturing unit across world. These manufacturing units are located in India, the US, Brazil, Canada, Egypt, Hungary, Israel, Bangladesh, Mexico, Romania, Ireland, Morocco, Nigeria, South Africa and Malaysia. In US, Sun Pharma has 7 own finished goods manufacturing units and one API manufacturing unit. These units are located in Philadelphia, Detroit, Wilmington, Chicago, Cranbury, New Brunswick, North Brunswick and API unit is located in Chattanooga. Sun Pharma first created its presence in US pharma market in 1996.

2. Lupin

Lupin Pharmaceuticals, Inc. entered the U.S. generic pharmaceutical market in 2003 with the ANDA approval for Cefuroxime Axetil Tablets. Since then Lupin has received more than 75 FDA approvals and have become one of the fastest growing pharmaceutical companies in the US. Lupin Limited, has its headquartered in Mumbai, India founded by Desh Bandhu Gupta.
The United States remains Lupin’s largest and most important market with 48% share of total revenues. In March 2016, the Company completed its acquisition of US-based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). The Somerset, New Jersey is the Company’s first manufacturing site in the US. In FY 2017 Lupin’s US revenues surpassed the USD 1 billion mark, closing at USD 1,207 million, a growth of 37% over FY 2016 revenues of USD 883 million. The revenues from Lupin’s Brands business were USD 78 million, while the Generics business clocked in revenues of USD 1,129 million. 

Dr. Reddy’s Laboratories is a Hyderabad, Telangana based Indian multinational pharmaceutical company founded in 1984 by Dr. K. Anil Reddy. Dr Reddy’s supplies Generic medicines to more then 80 countries world wide. In the year 1997, Dr. Reddy filled first ANDA with the United States Food and Drug Administration for Ranitidine. Dr. Reddy became the first Indian company to win 180-day exclusivity for a generic drug in the US. Also, Dr. Reddy launched their first generic product, Ranitidine, in the US market. In the year 2003, Dr. Reddy launched Ibuprofen, first generic product to be marketed under the ‘Dr. Reddy’s’ label in the US. During the year 2010-11, the company acquired GlaxoSmithKline’s (GSK) oral penicillin manufacturing facility located in Tennessee, USA. Dr. Reddy has its three manufacturing units in USA located at Shreveport (Louisiana), Bristol (Tennessee) and Middleburgh (New York). Dr. Reddy’s Laboratories Inc. has its American office located in Princeton, New jersey.

4. Cipla
Cipla is an Indian Multinational Pharmaceutical having its headquarter in Mumbai, India founded by Dr. Khwaja Abdul Hamied as The Chemical, Industrial and Pharmaceutical Laboratories in 1935 which is then shorted to Cipla ltd in 1984. Cipla has its presence in more than 100 countries. Cipla USA Inc., the US subsidiary of Cipla Limited, is based in Miami, FL. Cipla started US market in 1985, when Cipla became the first Indian company to receive US FDA approval. Cipla has place in top fifteen generic pharmaceutical companies in USA. Cipla completed acquisition of InvaGen Pharmaceuticals Inc. and Exelan Pharmaceuticals Inc. in USA to increase its presence.  InvaGen has 3 manufacturing units with ~350,000 sq.ft. manufacturing and R&D area and about 500 employees specialized in different fields. 

Aurobindo Pharma Limited is an Indian Pharmaceutical having its headquarter in HITEC city, Hyderabad, India founded in 1986 by P.V. Ramprasad Reddy and K. Nityananda Reddy. Aurobindo Pharma USA Inc. operates as a subsidiary of Aurobindo Pharma Limited manufactures generic pharmaceutical drugs. The company was incorporated in 2004 and is based in Dayton, New Jersey.  Aurolife is a 100% owned subsidiary of Aurobindo Pharma USA Inc (APUSA) has 100,000 square feet state-of-the-art US FDA approved cGMP compliant manufacturing facility. 

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What is Recall in Pharmaceutical Industry? Procedure involved in Product Recall

Product Recall means any action/procedure taken by the manufacturer, importer, marketer, supplier or registrant or enlistment holder of a product to remove it from the market or to retrieve from any person to whom it has been supplied because of the reason that the product;-

  • may be hazardous to health; or/and
  • may fail to conform to any claim made by its manufacturer, importer, registrant or enlistment holder relating to the quality, safety, efficacy or its usefulness; or/and
  • may not meet to the Quality Requirements;
Factors affecting Product Recall:
A pharmaceutical product may be recall from many reason as discussed above and other than discussed above. Due to complex distribution system and time taken process, 100% product recall from market is not possible. How much product will be received back depend at many factors like:
  • Time duration between manufacturing of batch and recall of product
  • Batch Size of Product recall
  • Nature of Product i.e. OTC, Prescription etc
  • Number of persons involves in Distribution Channel
  • Demand and Supply Ratio of Product (Consumption of Product)
  • Coverage Area of Product
  • Transportation Facilities, Time and Expanses during Recall
  • Expiry Date of Product
Types of Product Recall:
  • Voluntary
  • Requested by Authorities
Voluntary Product Recall:
If Product’s Manufacturer, importer, marketer, supplier or any other person involved in product distribution channel recall the product by itself  by finding product of inferior quality in re-checking, re-testing or any other way then it is Known as Voluntary Product Recall.

Requested by Concern Drug Authority:
If any Government Authority at concerned country responsible for pharmaceutical products standards and quality measures, finds product is not of standard quality (Failing of samples taken time by time) may request to concern person, institute or organisation to recall that product from market in Public interest.
In case concern person, institute or organisation don’t recall product at concern authority then concern authority may use its power to recall or force manufacturer or any other concern person to recall that product from market  
Procedure of Product Recall:
When a product is identified as of inferior quality or not of required standards, a product is recalled by its manufacturer, importer, marketer, supplier or any person involved into distribution channel. A product recall procedure involve following steps:
Step 1: In case of product recalled on request by Authority, Authority issue a letter confirming that product found of inferior quality or may not comply with standards as prescribed to the manufacturer, importer, marketer, supplier or any person involved into distribution channel. Involved person has to reply this letter at specific period of time. This letter may contains other required documents or details by drug authorities. Generally this letter asking the details as follow:
  • Confirmation of supply to whom sample taken
  • Source from where you obtained product (If you are not manufacturer)
  • Detailed Distribution report of that product along with invoice number, date and quantity
  • Issuing Recall letter to concern persons to whom you supply that product
  • Stock present at you
  • Attached list of test report issued by Authority Laboratory confirming found specification during testing
  • Any other detail if required 
In case of Voluntary Recall this step doesn’t involve. Internal test laboratory or any other laboratory confirms about product inferiority or lack of specific standards and starts recall procedure itself.

Step 2: Receiver has to reply the letter issued by concern drug authorities and Issue Recall Letter to all concern persons, firms, institutions or organisations to whom product has been supplied.
If you are a Pharmacy, then mention source of product as distributor or Stockist. Your customers to whom you supplied will be patients. If you are a Distributor or stockist then mention source of product as C&F or Manufacturer or Marketer or Importer. Distribution report will include all pharmacies chemist/retailers. If you are Carrying and Forwarding Agent (CNF) then mention source of product as Manufacturer or Marketer or Importer. Distribution list will include Distributors and Stockist detail. Marketing Companies or Importers will have to mention manufacturers from which to get manufactured or imported that product. Its Distribution report will include CNF or Stockist or Distributors. Manufacturer has to submit his own Certificate of Analysis reports and other testing quality procedure details carries during manufacturing of that product. And distribution report.

Step 3: A Recall letter has been issued by Manufacturer, importer, marketer or any other concern person. A manufacturer will issue Recall letter to CNF or Marketer or Importer. A CNF or Marketer or Importer will issue recall letter to Distributors or Stockists or CNF. A Distributor or Stockist will issue Recall Letter to Pharmacies/Retailers/Chemist. Further Pharmacy/Chemist may ask for return of product to patients but it’s practically not possible. Either patient may have consume it or it is difficult to locate patient easily. 

Step 4: Receiving of Recalled Stock and Destroyed by Manufacturer in presence of Concern Authorities.

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What is Quality Control? Basic Requirements for Quality Control

Quality Control means that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The basic requirements of quality control are that

  • Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes
  • Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by quality control
  • Test methods are validated
  • Records are made, manually or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated
  • The finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorization, are of the purity required, and are enclosed within their proper containers and correctly labelled
  • Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures
  • No batch of product is released for sale or supply prior to certification by an authorized person that it is in accordance with the requirements of the relevant authorizations
  • Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced
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