New Delhi: Drug Director of India (DCGI) is prepared by the instruction of states and trade unions to identify and act against drug manufacturers that, according to two official matters, do not follow good production procedures (GMP).
GMP is intended to ensure consistent quality and quality control, essential for patient safety, product efficiency and prevention of false drugs.
The recent revision of the GMP Plan M GMP is trying to align India quality standards with global benchmarks in an effort to increase the reputation of the country as a reliable drug manufacturer.
All large companies with income exceeding £250 Crore, implemented by GMP while smaller companies have received an extension until 31 December to make the necessary upgrades.
“Those who applied for the implementation of GMP and upgraded their facilities have been given time until December. Now state governments must verify compliance with companies that have not been used. DCGI can now issue the state/UTS to explore and identify companies.
“This matter was also discussed sometimes back, including Aayog, Pharma Association and Central Drugs Standard Control Organization (CDSCO),” the second official said.
About 8,500 out of 10,000 Indian pharmaceutical companies are small businesses, focused in Mahari, Gujarat, Himachal Pradesh and Andhra Pradesh. Only 2,000 of these MSME currently have GMP certification from the World Health Organization.
According to government estimates, the Indian pharmaceutical market was awarded an estimated $ 50 billion in FY 2023-24, with home consumption of $ 23.5 billion.
Worldwide, the Indian pharmaceutical industry is the third largest volume and 14. The largest by value, the most important supplier of generic drugs around the world, contributes to approximately 20% of the global offer.
This includes the production of approximately 60,000 general brands across 60 therapeutic categories. Key segments in this robust industry include generic drugs, over -the -counter medicines, volume medicines, vaccines, research and production of contracts, biological similarity and biology.
In 2023, the government revised the plan of the 1945 drug and cosmetics rules, which is compulsory for the NEW GMP standards for drug manufacturers. This was originally related to the annual income companies £250 crore and higher and now has been extended to MSME drug companies.
This was caused by incidents of contaminated Indian syrups coughing leading to the deaths of children in Gambia and Uzbekistan two years ago.
Harish Jain, President of the Federation of Pharmaceutical Entrepreneurs (FOPE), said that micro, small and medium -sized enterprise (MSME) drug companies that have applied for an extension from the drug regulator to implement good production practice (GMP) compliance with the agreed time frame. He added that any companies that do not look for extensions are assumed that they are already adhere to GMP protocols.
Dr. RV ASOKAN, former President of the Indian Medical Association (IMA), said that when the Indian pharmaceutical industry has increased exponentially in the last 25 years, the power to approve drugs was delegated from the Central Drug Authority (CDA) to the state authorities for drugs.
Small states such as Uttarakhand and Himachal Pradesh benefit from business friendly regulations and GMP have not been strictly forced.
“Due to the lack of infrastructure and ensuring the quality of human resources, it is less than satisfactory. The shortcomings, due to the lack of GMP regulations, may vary from one company to another. These gaps could be around storage, production, waste management, ventilation and infrastructure in Pharma units.”
Questions sent to the Ministry of Health remained unanswered until the press.
(Tagstotranslate) Drug Quality (T) World Health Organization (T) Niti Aayog (T) Drug Contient of General Veláře India (T) Pharmaceutical Product (T) MSME (T) Indian Medical Association (T) Waste Late
