LIST OF SCHEDULES AS PER DRUGS AND COSMETIC ACT 1948

Indian pharmaceutical GMP guidelines are given in Drugs & Cosmetics Act 1940. Rules are given for pharmaceuticals and schedules are there to comply those rules.

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act.

It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.

Different type of forms are also given for different type of approvals from drug authorities.

Following are the schedules:

Schedule A: Forms and applications

Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories

Schedule C: Biological and Special Products

Schedule C(1): Other Special Products

Schedule D: Class of Drugs: Extent and conditions of exemption

Schedule D(I): Information and undertaking required to be submitted by the manufacturer of his authorized agent with the application form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a computer floppy.

Schedule D(II): Information required to be submitted by the manufacturer or his authorized agent with the application form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a computer floppy.

Schedule E: Omitted

Schedule E(1): List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine

Schedule F: Part I to Part XII-A – Omitted

Part XII-B: Requirements for the functioning and operation of a Blood Bank and / or for preparation of Blood Components
(I) Blood Banks / Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank
Part XII-C:

(I)  Requirements for manufacture of Blood Products

(II)  Requirements for manufacture of Blood products from bulk finished products

Part XIII: General

Schedule F(I):

Part I: Vaccines

(A) Provisions applicable to the production of Bacterial Vaccines

(B) Provisions applicable to the production of Viral Vaccines

Part II: Antisera

           Provisions applicable to the production of all sera from living animals

Part II: Diagnostic Antigens

           Provisions applicable to the manufacture and standardization of Diagnostic Agents (Bacterial Origin)

Part IV: General

Schedule F(II): Standards for Surgical Dressings

Schedule F(III): Standards for umbilical Tapes

Schedule FF: Standards for Ophthalmic Preparations
Schedule G:
Schedule H: Prescription Drugs

Schedule I: Omitted

Schedule J: Disease and ailment (by whatever name described ) which a drug not purport to prevent or cure.

Schedule K: Class of drug: Extent and conditions of exemption

Schedule L1: Good Laboratory Practice

Schedule M: Good manufacturing practices and requirements of premises,  plant and equipment for Pharmaceutical product.

Part I: Good manufacturing practices for premises and materials.

Part I-A: Specific requirements for manufacture of sterile products, parenteral preparation (small volume injectables and large volume parenterals ) and sterile ophthalmic preparation  

Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).

Part I-C: Specific requirement for manufacture of oral liquids (Syrups, elixirs, emulsions and suspensions).

Part I-D: Specific requirements for manufacture of topical products i.e. external preparation (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products) 

Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)

Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).

Part II: Requirements of plant and equipment.

Schedule M-I: 1. Requirements of factory premises for manufacture of homoeopathic preparations.

2. Requirements of plants and equipments.

Schedule M-II: Requirements of factory premises for manufacture of cosmetic.

Schedule M-III: Requirements of factory premises for manufacture of medical devices.

Part I-B: Specific requirement for manufacturing of oral solid dosage forms  (Tablet and Capsules).

Part I-C: Specific requirement for manufacture of oral liquids ( Syrup, elixirs, emulsions and suspensions).

Part I-D: Specific requirements for manufacture of topical products i.e. external preparation ( creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products )  

Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)

Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).

Part II: Requirements of plant and equipment.

Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy

Schedule O: Standard for Disinfectant Fluids

Schedule P: Life Period of Drugs

Schedule P1: Pack Sizes of Drugs

Schedule Q: List of Dyes, colours and Pigments permitted to be used in Cosmetics and Soaps as given under IS : 4707 (Part I)-1988 as amended by the Bureau of Indian Standards

Schedule R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives

Schedule S: Standard for cosmetics.

Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.

Schedule U: I – Particulars to be shown in the manufacturing records.

                   II – Records of Raw Materials.

                   III – Particulars to be recorded in the analytical records.

Schedule U(I): I – Particulars to be shown in manufacturing records.

                       II – Records of Raw Material.

Schedule V: Standards for patent or proprietary medicines.

Schedule W: Omitted

Schedule X

Schedule Y: Requirements and guidelines for permission to import and/or manufacture of New Drug for sale or to undertake clinical Trials.

METHOD FOR PREPARATION OF LIPSTICK

Formulation and manufacturing of Lipstick
Lipstick:-
Lipstick is a cosmetic product containing pigments, oils, waxes, and emollients that apply color, texture, and protection to the lips.
Lipstick Raw Materials 
Before making lipstick, ingredients must be chosen. The primary ingredients of every lipstick are waxes, oils, and pigments, but many other substances can be introduced into the mix that will enhance certain parts of the final product and add it some specific new features such as fragrance, longevity and gloss.

The wax used usually involves some combination of three types : beeswax, candelilla wax or the more expensive carnauba. Wax enables the mixture to be formed into the easily recognized shape of the cosmetic. Oils such as mineral, caster, lanolin, or vegetable are added to the wax.

Some of the most common secondary ingredients are preservatives (to ensure longer shelf life), alcohol (solvent for other substances), fragrance (oils and waxes can sometimes have their own smell and taste, which needs to be eliminated), antioxidant and others wide vaiety of other ingredients can also be included to make the substance smoother or glossy or to moisten the lips.

Lipstick tube
The tubes that hold lipstick range from inexpensive plastic dispensers for lip balms to ornate metal for lipsticks. Sizes are not uniform, but generally lipstick is sold in a tube 3 inches (7.6 cm) in length and about .50 inch (1.3 cm) in diameter. The tube has two parts, a cover and a base. The base is made up of two components, the twisting or sliding of which will push the lipstick up for application.

Description of Machinery in Lipstick Manufacturing 

1. Mixing Machine
2. Seizing Machine
3. Grinding Machine: Tri-Roller Rolling Machine and Successive High speed Moleculized Instrument – wet model 
4. Heating Mixing Machine for pearl ointment 
5. Mold Sets 
6. Filling Machine: Basic Type(conventional), Plate Type. Semi-Automatic Type, Fully Automatic Type 
7. Mold Releasing Machine By Air Blowing Machine 
8. Box Folding Machine 
9. Cartoning Machine 
10. Carton Tapping Machine 

Lipstick Manufacturing Process
In general, wax and oil make up about 60% of the lipstick (by weight), with alcohol and pigment accounting for another 25% (by weight). Fragrance is always added to lipstick, but accounts for 1% or less of the mixture.

The most common lipstick manufacturing procedure is done in four stages.

1. Pigment milling, in which you chose desired pigment, or the combination of pigment and then carefully mix them. Then, pigment is melt with oils or other fat good. The granule uniformity and particle distribution will be grinding by grinder to get optimization. The formula put through three-roll mill which grind ever particle usually to the size of 20 microns. Common ration of oil and pigment is 2 to 1 particles. 
2. Combination of pigment phase into base wax is done with simple mixing of those liquids in a steam-jacketed kettle that is equipped with one propeller agitator. After successful mixing, resulting liquid is again put through three-roll mill and usually grinded down to particle sizes of 20 microns. Perfume will be mixed within the paste phase under certain temperature and continuous agitating. 
3. Molding. Once the lipstick mass is mixed and free of air, it is ready to be poured into the tube. Molding is done at specific temperatures to eliminate certain unwanted products of fast cooling. Lipsticks liquid that is heated to around 80 C is poured into vertical split molds that are kept at temperature of around 35 C. To prevent formation of air bubbles in the molds, manufacturers often use slightly tilted molds or use vacuuming to forcefully extract any air. A variety of machine setups are used, depending on the equipment that the manufacturer has, but high volume batches are generally run through a melter that agitated the lipstick mass and maintains it as a liquid. For a smaller, manually run batches, the mass is maintained at the desired mix temperature, with agitation, in a melter controlled by an operator. 
4.  Resulting lipstick is cooled down, extracted from the molds and prepared for flaming (passing of the sticks near one or several open flame torches or flaming cabinet that will meltsmall layer of gloss around lipsticks). This procedure will ensure better visual appearance of the lipstick, and protection from outside air and influences (lipsticks can become rancid after prolonged exposure to air, moisture and heat). 
5. Packaging and labeling is done with the requirements of the manufacturers of brand owner. After the lipstick is retracted and the tube is capped, the lipstick is ready for labeling and packaging. Labels identify the batch and are applied as part of the automated operation. There are a variety of packaging options available, ranging from bulk packs, and including packaging as a component in a makeup kit or special promotion offering. Packaging for lipstick varied, depending on what will happen at the point of sale in the retail outlet. Packaging may or may not be highly automated, and the package used depends on the end use of the product rather than on the manufacturing process. 

PIC (Process in Control) 

Air Bulb removing, There are many chances to crease air bulb within the paste during melting, mixing, and agitating.

The method of de-gas from the paste is set the paste without moving for certain time for enable the light weight air bulb floating up to the surface of paste form material.

Therefore, the bottom portion of the paste material will be applied as material to fill the lipstick molds. However, please care of the powder, color agent or particle sediment from the paste.

Quality Control in Lipstick Manufactruring

Lipstick product must meet FDA standards. Lipstick is the only cosmetic ingested, and because of this strict controls on ingredients, as well as the manufacturing processes, are imposed. Lipstick is mixed and processed in a controlled environment so it will be free of contamination. Incoming material is tested to ensure that it meets required specifications. Samples of every batch produced are saved and stored at room temperature for the life of the product to maintain a control on the batch.

Color control of lipstick is critical. The dispersion of the pigment is checked stringently when a new batch is manufactured, and the color must be carefully controlled when the lipstick mass is reheated. The color of the lipstick mass will bleed over time, and each time a batch is reheated, the color may be altered. Colorimetric equipment is used to provide some numerical way to control the shades of lipstick.

There are two special test for lipstick :

1. The Heat Test. Lipstick is placed in the extended position in a holder and left in a constant temperature oven of over 130 degrees Fahrenheit (54 degrees Celsius) for 24 hours. There should be no dropping or distortion of the lipstick.
2. The Rupture Test.  Lipstick is place in two holders, in the extended position. Weight is added to the holder on the lipstick potion at 30-second intervals until the lipstick ruptures. The pressure required to rupture the lipstick is then checked against the manufacturer’s standards.