Karnataka pharma industry is optimistic about the Good Distribution Practices (GDP) draft guidelines and views it as a milestone move by the union health ministry. They felt that it was high time the industry was kept away from being blamed for the poor drug transportation and storage.
The state industry captains spanning from small to medium and large companies conveyed that this could be the best of the implementations which have come so far as a stringent regulation in this segment was found wanting for a long time now.
“The move by the Union government is a sagacious approach to help solve the problem of counterfeit medicines. Furthermore, implementation of GDP will help strengthen India's image as a professional and highly responsible and reliable producer and marketeer of quality drugs covering allopathic, ayurvedic and homoeopathic formulations and also active pharmaceutical ingredients. GDP concept is gaining traction at the right time in India, and the government should give a fillip and ensure implementation of this approach,” said SG Biligiri, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and technical director, Juggat Pharma.
On the domestic pharma scene, GDP will help streamline distribution chaos and create transparency of distribution accounting. It will help weed out distribution malpractices. The availability of IT infrastructure and architecture will help GDP implementation. All stakeholders should be an intrinsic part of GDP creation and execution for relevant 'buy-ins' - this should include bodies like AICOD, KDPMA, IDMA etc. The government should offer incentives to distributors and manufacturers so that technologies like RFID, bar coding etc. are adopted universally, stated Biligiri.
India is steadily making inroads into the hightech global bio-generics and rDNA product market. To ensure that India's fortunes in the biopharma ventures rock steady, the GDP guideline document is seen to be forward looking, averred the KDPMA president.
Airing a similar view was Gurudatta GG, chief executive officer, Estima Pharma Solutions, who said that good distribution practices are a must for India. So long such temperature mapping procedures and compulsory product recalls within a stipulated period were absent in India. It put the pharma industry in serious trouble when good storage methods were failed to be maintain after the drugs were transported from their premises.
So long the industry was forced to face charges of not-of-standard quality drugs either by the retail or wholesaler pharmacies along with the regulatory enforcement inspectors. Now with such a guideline on the anvil, it would no longer make us culpable, said officials from Micro Labs.
Giving an example of MCC, the South African regulatory authority which mandates audits of pharmaceutical storage warehouses and issues licenses to drug distributors only if rules are adhered to, the Estima Pharma chief called for similar initiatives in India too.
Harish K Jain, director, Embiotic Laboratories (P) Ltd said that while GDP guideline was a bold decision, yet its implementation was seen as a challenge. No doubt it is a huge task to see not only if temperatures are maintained but if records are maintained accurately about the same. Another issue is the ability to invest for refrigerated units, cold storage equipment and infrastructure which is expensive. There are serious apprehensions about the affordability for distributors and retailers as many of them are small and unwieldy enterprises.