Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember
Manner of labelling:
(1) Subject to other provisions of the rules, a cosmetic shall carry on both the inner and outer labels:
(a) the name of the cosmetics,
(b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as ―Made in ........ (name of country)" should be there on the label: Provided that if the cosmetic is contained in a very small size container as 30gm or less if the cosmetics are in solid or semi-solid state and 60 ml or less if the cosmetics is in liquid state, where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code
(c) use before or date of expiry(month and year) or use by or expiry date or expiry XX months from manufactured or date of manufacturing or expiry date.
(1) Subject to other provisions of the rules, a cosmetic shall carry on both the inner and outer labels:
(a) the name of the cosmetics,
(b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as ―Made in ........ (name of country)" should be there on the label: Provided that if the cosmetic is contained in a very small size container as 30gm or less if the cosmetics are in solid or semi-solid state and 60 ml or less if the cosmetics is in liquid state, where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code
(c) use before or date of expiry(month and year) or use by or expiry date or expiry XX months from manufactured or date of manufacturing or expiry date.
(2)
(a) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter "B" or the words Batch No. or B. No. or Batch or Lot No. or Lot shall carry on the inner or outer labels: Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state and 25 milliliters or less if the cosmetic is in a liquid state: Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.
(b) Manufacturing licence number, the number being preceded by the letter M or M. L. No or Mfg. Lic. No. shall carry on the inner or outer labels, Provided that in case of imported products, if such provision is not mandatory in country of origin, such cosmetics may be allowed without mentioning manufacturing license number, subject to fulfillment of other import regulations.
(a) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter "B" or the words Batch No. or B. No. or Batch or Lot No. or Lot shall carry on the inner or outer labels: Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state and 25 milliliters or less if the cosmetic is in a liquid state: Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.
(b) Manufacturing licence number, the number being preceded by the letter M or M. L. No or Mfg. Lic. No. shall carry on the inner or outer labels, Provided that in case of imported products, if such provision is not mandatory in country of origin, such cosmetics may be allowed without mentioning manufacturing license number, subject to fulfillment of other import regulations.
(3) The outer label of the cosmetics shall carry a declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, fluid measure or weight for semi-solids, combined with numerical count if the content is sub-divided:
Provided that this statement need not appear in case of a package of perfume, toilet water or the like, the net content of which does not exceed 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams.
Provided that this statement need not appear in case of a package of perfume, toilet water or the like, the net content of which does not exceed 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams.
(4) In case of cosmetics; where a hazard exists, every inner label shall clearly indicate
(a) adequate directions for safe use,
(b) any warning, caution or special direction required to be observed by the consumer,
(c) a statement indicating the names and quantities of ingredients that are hazardous or poisonous.
(a) adequate directions for safe use,
(b) any warning, caution or special direction required to be observed by the consumer,
(c) a statement indicating the names and quantities of ingredients that are hazardous or poisonous.
(5) In the case of imported cosmetics to be marketed in India, import registration certificate number shall be mentioned on the label of unit pack preceded by letter RC or RC No or Reg. Cert. No along with name and address of the importer;
(6) Where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these rules.
(7) In all cases, the list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one percent, in any order, and preceded by the words "INGREDIENTS"
Provided that this statement need not appear for packs of less than or equal to 60 ml of liquid and 30 gm of solid and semi-solids.
(8) The cosmetic shall comply with labelling requirement, if any, specified in the relevant Indian standard as laid down by the 'Bureau of Indian Standards' for the cosmetics covered under the Ninth Schedule.
(9) No cosmetic shall be imported unless it is packed and labelled in conformity with these rules and the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India:
Provided further that in cases where the imported cosmetics require India specific labelling, the same shall be allowed to be stickered on the unit pack at the bonded warehouses.
(10) In case, the cosmetic is meant for export then the labels on packages or container of cosmetic shall meet the specific requirements of law of the country to which the cosmetic is to be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack of the cosmetic in which the cosmetic is packed and every other outer covering in which the container is packed:
(a) name of the cosmetic;
(b) the distinctive batch number or lot number or serial number preceded by the word Lot No. or Lot or Batch No. or B. No. or Serial No. or B;
(c) use before or date of expiry, if any;
(d) the name and address of manufacturer and address of actual premises where the cosmetic has been manufactured;
(e) licence number preceded by letters Licence No. or Lic. No.;
(f) internationally recognised symbols in lieu of text, wherever required:
Provided that where a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the state Licensing Authority.
Check out Detail about: How to start Cosmetic Manufacturing Unit in India?
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