Why licenses of Pharma companies became so Important?
When the pandemic hit hard and the world is yet healing from its impact in all strain to be said, monetarily and mentally and most important physically. By the end of time, one thing is realised by all the people strongly and vividly ‘Health is Wealth’ and it is you who would suffer if ignored. Now it becomes extremely important to put great endeavour while choosing the products on to whom to rely upon. Have said, for external applications and internal ones, especially.
Replication of the Drugs
Talking about the internal dosage that we consume on daily basis, like paracetamol and crocin and others are familiar names and everyday players in the market. Nevertheless, the union government under the Drugs Controller General of India (DCGI), had cancelled the license of 18 companies to manufacture spurious drugs. The call for action was usurped when syrups manufactured by Haryana-based company- Maiden Biotech, caused death to children in the Gambia and another Noida-based company, Marion Biotech caused death in Uzbekistan of minor children.
In lieu of it, another incident came to the surface where a Chennai-based eyedrop company, adversely affected the eyes due to sub-standard quality of the eye droplets and moreover, resulting in, loss of vision and death due to bloodstream infection in the USA.
Possible Implementations/ Solutions
In a meeting headed by the Union Health Ministry along with the drug regulators and other stakeholders at a Chintan Shivir, a possible conclusion is drawn towards betterment implantation of Schedule - M of the Drugs And Cosmetics Act, 1940. A brief introduction is stated for a better understanding of what to expect further,
SCHEDULE M - GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS.
PART – I- GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS.
PART I-A - SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS.
PART I-B - SPECIFIC REQUIREMENTS FOR THE MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES).
PART I-C - SPECIFIC REQUIREMENTS FOR THE MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS)
PART I-D - SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, EMULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS)
PART I-E - SPECIFIC REQUIREMENTS FOR THE 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 - REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF HOMOEOPATHIC PREPARATIONS.
SCHEDULE M-II - REQUIREMENT OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS.
SCHEDULE M-III - REQUIREMENTS OF FACTORY PREMISES FOR THE MANUFACTURE OF MEDICAL DEVICES
Under these broad headings, further action is expected by the Heath Ministry to take. A detailed version of Schedule M, along with the table and relevant rules under the Drugs And Cosmetics Rules. No doubt, this long set of rules and procedures are laid down by the government and bringing constant amendments to it, still, persistent active action is required to be taken to avoid any negligent acts of the manufacturer for human price. What can be done is that the most practical and substantial should be structured along the lines of WHO- GMP (Good Manufacturing Practices) which is harder for any developer follows.
In addition, the Parliament is drafting regulations for e-pharmacy stores with stronger actions to avoid data privacy concerns, fraudulent practices and ‘irrational’ sales of drugs.
The fresh regulations are proposed to be incorporated in an upcoming revised version of the New Drugs, Medical Devices and Cosmetics Bill, 2023 to deal with the manufacturing and supply of drugs and cosmetics.
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