From factory to pharmacy: Will new transit rules ensure safer drugs?
Proposed new guidelines also call for clear traceability rules for everyone handling these medicines, starting from their origin to their user, to prevent spurious and substandard drugs entering the supply chain, said two government officials aware of the development.
Currently, the rules are lax about storage during transit and are not mandatory, leading to concerns about their quality. A special committee, chaired by India's apex drugs regulator—Drugs Controller General of India (DCGI)—met recently and discussed the draft rules.
These propose that each stage of packaging must have printed 2D barcodes along with legible text containing important details including the unique product code (GTIN), batch number, expiry date, manufacturing date, and a serial number.
This will help track medicines through their transit journey. In addition, every entity handling the transportation must record details of the product, receivers and senders, and the time and place of transaction.
This comes in the backdrop of the Central Drugs Standard Control Organization (CDSCO) developing a comprehensive national action plan to combat substandard and spurious medical products in the country as reported by Mint earlier.
There have also been instances when medicines meant for hospitals (marked "not for retail sale") have been mixed with regular pharmacy stocks, amid complaints about 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 current guidelines aren't mandatory, which means drug manufacturers aren't consistently ensuring proper storage conditions until the products reach wholesale and retail levels. To address this, a draft guideline has been prepared, aligning with updated WHO (World Health Organization) standards. However, the proposed guideline needs to be discussed with stakeholders including the drug manufacturers and distributors before any final decisions are made," said one of the government officials cited above requesting anonymity.
The proposed rules call for Good Storage Distribution Practices (GSDP) that are essential to ensure the quality, safety, and efficacy of medicines throughout the supply chain from the manufacturer to the end-consumer.
Medicines are sensitive products that can degrade due to improper storage, exposure to extreme temperatures, or mishandling during transit. GSDP also helps in stopping fake and substandard drugs from getting into the market, and allows for tracking.
'Right now, these crucial guidelines aren't a mandatory part of the Drugs Rule, 1945. Therefore, the plan is to put good storage and distribution practices in the Drugs Rule, thereby making them a legal requirement for everyone involved, including drug manufacturers, distributors, and retailers. This will ensure that medicines maintain their quality and effectiveness across the entire supply chain. A draft notification will be issued to make this provision legal, once things are finalised," said the second official cited above who also did not want to be named.
The development assumes significance given that India's pharmaceutical market is valued at $50 billion and is ranked the third-largest by volume and 14th by value. India is the largest global supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic drugs across 60 therapeutic categories.
Queries emailed to the spokespersons of the health ministry and DCGI remained unanswered till press time.
Rajiv Singhal, General Secretary of All India Organization of Chemists and Druggists (AIOCD), which says it represents about 1.2 million chemists and distributors across India, said that everyone involved has an important role to play.
'Wholesalers and distributors also need to report any suspicious or fake drugs. They need to store medicines properly. Pharmacies and chemists should also store drugs as recommended, check their quality and expiry dates before selling them, keep good records of sales and purchase, and educate the patients on how to use and store medicines safely," Singhal said.
Manufacturers say the Centre's initiative to introduce mandatory 2D barcoding and comprehensive traceability across the pharmaceutical supply chain is a much-needed step.
'It will go a long way in tackling issues like counterfeiting, pilferage, and improper storage during transit. More importantly, it will create a culture of accountability across every stakeholder, from manufacturers to distributors to retailers. While there may be some implementation challenges for smaller players, the long-term gains in patient safety, quality assurance, and global confidence in Indian pharma far outweigh the short-term hurdles," said Entod Pharmaceuticals chief executive officer Nikkhil K. Masurkar.
'We view drug delivery as a critical extension of our commitment to quality and patient safety. Ensuring that medicines are transported and handled under controlled, compliant conditions is as important as how they are manufactured. We've invested in robust cold-chain systems, GPS-enabled tracking, and tamper-evident packaging to maintain product integrity throughout the supply chain. Drug delivery is not just about logistics, it's a matter of public health," added Masurkar, whose company manufacturers medicines such as specializing in ophthalmology, ENT (ear, nose, and throat), and dermatology.
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The Hindu
14-07-2025
- The Hindu
The paradox of market restriction for anti-TB drugs
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India, like many countries in the world, procures most of its anti-TB drugs from the Global Drug Facility (GDF ) , a not-for-profit establishment funded by the Global Fund, along with procurement via domestic funding through the Central Medical Services Society . GDF does not aim to make a profit and therefore provides drugs and consumables at very low prices to countries through bulk procurement. The Central TB Division places an order to GDF at least one year prior by forecasting the need, based on the disease burden in the country. The drugs are then routed through Government Medical Store Depots to State Drug Stores of NTEP, from where they go to District Drug Stores and then down to DOTS centres at Tuberculosis Units and Peripheral Health Institutions. This entire process is managed real-time through a portal called Ni-Kshay Aushadh i , which is accessible only to NTEP personnel. The Central procurement of drugs is based on drug requests received from peripheral health institutions at the grassroots level. Timely online drug requests through the Ni-Kshay Aushadhi portal are imperative for uninterrupted procurement and supply of drugs in NTEP. However, studies have shown the sub-optimal use of the portal in the field owing to various reasons like lack of digital literacy and training of peripheral level staff, portal interface not being user-friendly and stock planning and forecasting not being perceived as a 'felt need' by staff. Why restrict access to newer anti-TB drugs A new drug that is developed can be patented by the company that developed it (originators) for a minimum of 20 years. No other company can undertake commercial production of the drug during this period. However, when a drug goes off-patent (expiry of patent period), it can be manufactured by any other pharmaceutical company and can be marketed for use. 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PwTB and their families had to run from pillar to post to obtain drugs needed daily for even the most common DS-TB regimen. Since the NTEP centres ran out of stock, a few PwTB who could afford it, sourced drugs from the open market. For persons affected by DR-TB, since drugs were available only through NTEP, they had to take incomplete regimens or miss their doses altogether. Lack of an alternative source to obtain drugs can be detrimental for PwTB if similar situations arise in future. Missed or incomplete doses can lead to delays in cure or no cure, increased risk of development of drug resistance and increased out of pocket expenditure for patients. This also leads to loss of trust in government systems built over several years, and in the larger picture, is a deterrent to our goal of TB elimination. Also Read: Gross mismanagement: On TB drug shortages and India's national TB programme What can be done? 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News18
14-07-2025
- News18
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Last Updated: The government said there is no challenge to Raghuvanshi's eligibility and several other petitions, now dismissed as withdrawn, were raised to block the reappointment The Union government has strongly defended its decision to re-employ Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi after his superannuation, calling the legal challenge to the move 'malafide" and 'speculative". The government has asserted that the appointment was made in public interest with the express approval of the Appointments Committee of the Cabinet (ACC). The DCGI heads the Central Drugs Standard Control Organisation (CDSCO)—the country's apex health regulatory authority overseeing the regulation, manufacture, import, export, sale, and distribution of medicines, cosmetics, vaccines, and medical devices. 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Mint
09-07-2025
- Mint
From factory to pharmacy: Will new transit rules ensure safer drugs?
New Delhi: India is working on new rules to ensure that medicines purchased by customers are safe and haven't lost their efficacy during transit from manufacturing units to the pharmacies. Proposed new guidelines also call for clear traceability rules for everyone handling these medicines, starting from their origin to their user, to prevent spurious and substandard drugs entering the supply chain, said two government officials aware of the development. Currently, the rules are lax about storage during transit and are not mandatory, leading to concerns about their quality. A special committee, chaired by India's apex drugs regulator—Drugs Controller General of India (DCGI)—met recently and discussed the draft rules. These propose that each stage of packaging must have printed 2D barcodes along with legible text containing important details including the unique product code (GTIN), batch number, expiry date, manufacturing date, and a serial number. This will help track medicines through their transit journey. In addition, every entity handling the transportation must record details of the product, receivers and senders, and the time and place of transaction. This comes in the backdrop of the Central Drugs Standard Control Organization (CDSCO) developing a comprehensive national action plan to combat substandard and spurious medical products in the country as reported by Mint earlier. There have also been instances when medicines meant for hospitals (marked "not for retail sale") have been mixed with regular pharmacy stocks, amid complaints about 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 current guidelines aren't mandatory, which means drug manufacturers aren't consistently ensuring proper storage conditions until the products reach wholesale and retail levels. To address this, a draft guideline has been prepared, aligning with updated WHO (World Health Organization) standards. However, the proposed guideline needs to be discussed with stakeholders including the drug manufacturers and distributors before any final decisions are made," said one of the government officials cited above requesting anonymity. The proposed rules call for Good Storage Distribution Practices (GSDP) that are essential to ensure the quality, safety, and efficacy of medicines throughout the supply chain from the manufacturer to the end-consumer. Medicines are sensitive products that can degrade due to improper storage, exposure to extreme temperatures, or mishandling during transit. GSDP also helps in stopping fake and substandard drugs from getting into the market, and allows for tracking. 'Right now, these crucial guidelines aren't a mandatory part of the Drugs Rule, 1945. Therefore, the plan is to put good storage and distribution practices in the Drugs Rule, thereby making them a legal requirement for everyone involved, including drug manufacturers, distributors, and retailers. This will ensure that medicines maintain their quality and effectiveness across the entire supply chain. A draft notification will be issued to make this provision legal, once things are finalised," said the second official cited above who also did not want to be named. The development assumes significance given that India's pharmaceutical market is valued at $50 billion and is ranked the third-largest by volume and 14th by value. India is the largest global supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic drugs across 60 therapeutic categories. Queries emailed to the spokespersons of the health ministry and DCGI remained unanswered till press time. Rajiv Singhal, General Secretary of All India Organization of Chemists and Druggists (AIOCD), which says it represents about 1.2 million chemists and distributors across India, said that everyone involved has an important role to play. 'Wholesalers and distributors also need to report any suspicious or fake drugs. They need to store medicines properly. Pharmacies and chemists should also store drugs as recommended, check their quality and expiry dates before selling them, keep good records of sales and purchase, and educate the patients on how to use and store medicines safely," Singhal said. Manufacturers say the Centre's initiative to introduce mandatory 2D barcoding and comprehensive traceability across the pharmaceutical supply chain is a much-needed step. 'It will go a long way in tackling issues like counterfeiting, pilferage, and improper storage during transit. More importantly, it will create a culture of accountability across every stakeholder, from manufacturers to distributors to retailers. While there may be some implementation challenges for smaller players, the long-term gains in patient safety, quality assurance, and global confidence in Indian pharma far outweigh the short-term hurdles," said Entod Pharmaceuticals chief executive officer Nikkhil K. Masurkar. 'We view drug delivery as a critical extension of our commitment to quality and patient safety. Ensuring that medicines are transported and handled under controlled, compliant conditions is as important as how they are manufactured. We've invested in robust cold-chain systems, GPS-enabled tracking, and tamper-evident packaging to maintain product integrity throughout the supply chain. Drug delivery is not just about logistics, it's a matter of public health," added Masurkar, whose company manufacturers medicines such as specializing in ophthalmology, ENT (ear, nose, and throat), and dermatology.
