The proposed new instructions also require clear traceability rules for anyone who deals with these drugs, from their origin to their user to prevent false and non -standard drugs entering the supply chain, two government officials who realized their development.
At present, the lax rules are storage during transit and are not mandatory, which leads to concern about their quality. A special committee, chaired by the Indian Apex Regulator Regulator – General Controller for Indian Control (DCGI) – recently and discussed the proposal of the rules.
They suggest that each phase of the packaging has to have printed 2D barcodes together with a readable text containing important details, including the unique product code (GTIN), a lot number, expiration date, date of production and serial number.
This will help follow the drugs through their transit path. In addition, each entity must record the transport of transport, details about the product, receivers and sending and time and the transaction site.
This comes against the background of the Central Draging Overbesting Organization (CDSCO), which develops a comprehensive national action plan for combating non -standard and false medical products in the country, as MINT previously reported.
There were also examples where medicines for hospitals (marked “not for retail sale”) were mixed with regular pharmaceutical supplies, in the middle of complaints for expired or damaged products.
“The Drug Consultative Committee (DCC) in Its Meeting Last Month Discussed An Important Issue of Drug Storage During Transit. It Was Noted that Currently Guidelines aren’t Mandatory, WHICH MEANS DRUG MANUFACTURERS AEN’T CONSISTLY WholeSale and Retail Levels. Finish decisions, ”said one of the above -mentioned government officials who demanded anonymity.
The proposed rules require good storage distribution procedures (GSDP), which are necessary to ensure the quality, safety and efficiency of the drug chain from the manufacturer to end consumer.
Medicines are sensitive products that may deteriorate due to incorrect storage, exposure to extreme temperatures, or incorrect handling during transit. GSDP also helps to stop fake and non -standard drugs in the market to reach and allow monitoring.
“Right now these fundamental instructions are not a compulsory part of the 1945 drug rule. Therefore, it is planned to put good storage and distribution practices into the drug rule, thus making them a legal requirement for all participants, including drug manufacturers, distributors, distributors and retailers as soon as they are official.” official. He also did not want to be named.
Development assumes importance as the Indian pharmaceutical market is awarded at $ 50 billion and is evaluated by the third largest volume and 14. India is the largest global supplier of generic drugs, which represents about 20% of global offers. It produces about 60,000 generic drugs in 60 therapeutic categories.
Questions by the spokesperson of the Ministry of Health and DCGI remained unanswered until the press.
Rajiv Singhal, Secretary General of All India Organization of Chemists and Druggists (AiOCD), says it represents about 1.2 million chemists and distributors throughout India, that all participants have an important role.
“Wholesalers and distributors must also report any suspicious or false medicines. They must store medicines correctly. Pharmacies and chemists should also store medicines as recommended, check their quality and expiry data, keep good sales and purchase records, and educate patients on how to use and store medications.
Manufacturers claim that the initiative of the introduction of the mandatory 2D barcoding and comprehensive traceability across the pharmaceutical supply chain is a much needed step.
“It will be a long way to solve problems such as counterfeiting, handcuffs and incorrect storage during transit. Even more important is that they create a culture of responsibility across all parties, from manufacturers to distributors to retailers. Entosu, “Enterch-Farmatie,” Enterch, “Enterch-Farm,” Enterch-Farmate, “she said in primary,” she said in first-class, “she said in Entos,” Enterch-Farmate, “Enterch-Farmate,” Entetivied, “EnterTeitional Tops, ‘Nikkhil K. Masurkar.
“We consider the supply of drug to critical prolongation of our obligation to the quality and safety of patients. Ensuring medicinal products is transported and processed under controlled, the conditions in accordance are as important as the way they are produced. We have invested in the robust systems of the studied chain, added GPS tracking,” dealing with the company dealing with the company. Specializing in ophthalmology, entho (ear, nose and neck) and dermatology.
(Tagstotranslate) Healthcare (T) DCGI (T) Pharmacy (T) Drug Delivery (T) India Rules for Drug Delivery (T) Who (T) Line Coding (T) Trackability
