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Manufacturing Batch Record for Cosmetics

I. Particulars to be shown in the manufacturing records:  (1) Serial number.  (2) Name of the product.  (3) Lot or Batch size.  (4) Lot or Batch number.  (5) Date of commencement of manufacture and date when manufacture was completed.  (6) Names of all ingredients, quantities required for the lot/batch size, quantities actually used.  (7) Control reference numbers in respect of raw materials used in formulation.  (8) Reference to analytical report numbers or unique code.  (9) Actual production and packing particulars indicating the size and quantity of finished packings.  (10) Date of release of finished packing for distribution or sale.  (11) Signature of the expert staff responsible for the manufacture.  II. Records of raw materials: Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of r

Branded medicines

Branded medicines are the medicines which has given a name for advertising purpose by a company. When a pharmaceutical company develops/researches a medicine molecule which is safe and effective for human use, pharmaceutical company is granted by exclusive rights so no other manufacturer can produce it for certain period of time which is known as patent.

Innovator Pharma Company gives a brand name for advertising purpose to this researched molecule which is different from its International Nonproprietary Name (INN) or generic name.

Branded medicine is referred to the medicines which are sold by its innovator by giving it a brand name. Example of certain branded medicines: Augmentin (co-amoxiclav) , Glucophage (Metformin), lopressor (metoprolol), Prilosec (Omeprazole) etc. In case of Augmentin (Co-amoxiclav), Augmentin is a brand name whereas Co-amoxiclav is its INN or generic name. Likewise for other examples quoted above.

After expiry of patent, other companies can also apply for approvals for manufacturing of this molecule. When other pharmaceutical companies start manufacturing of this molecule with a brand name or generic name then these companies’ products come under generic medicines.

Definition of Branded medicines varies country to country. For example, in USA, only one brand could be available for a particular molecule. Other companies can launch that molecule with generic names only after expiration of patent.

But in India, along with patent brand, other pharmaceutical companies are allowed to sell that molecule by giving it a brand name after expiration of patent or through compulsory licensing. Hence number of brands is available in Indian market for a particular molecule. These brands are given a term i.e. Branded Generics. Branded Generics are also sold with a brand name and almost same price as of its original brand. These are not generics but branded versions of generics.

Read: Difference between branded medicine and generic medicines

There are also one another term use for classifying medicine is Pseudo generic medicines. It is not the original patent product but same replica of the original by the Innovator Company with same ingredients but with other brand name or generic name to discourage competitor pharmaceutical companies from entering into market of that molecule.

Hope above information is helpful to you...
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