The government of India has brought into effect stricter norms for obtaining No Objection Certificates (NOCs) for pharmaceutical exporters.
The Central Drugs Standard Control Organization (CDSCO) – the apex body regulating pharmaceutical industry in India – has issued circular with effect from 1st January 2010, announcing a set new rules for exporters, reports said.
Exporters of pharma products now needs to submit documents including a shipping bill along with custom report to obtain no objection certificate (NOC) from the the Assistant Drugs Controller (ADC) for export of drugs and cosmetics.
The original copy of the invoice in duplicate should be signed by the authorized authority.
Certificate of analysis, current Good Manufacturing Practices (cGMP) certificates, certified copy of permission for production of the drugs and cosmetics in the list approved by the Central FDA or state drugs controller are among the other submissions mandated by the new regulation.
Exporters need also submit a sample of the drugs from the consignment sealed or signed by the customs officer, reports said quoting a circular No. ADC/TECH/BSZ dated January 1, 2010.
In the case of bulk drugs, exporters should get thier labels duly signed and stamped by the head of Quality Control or Quality Assurance department. The same practice needs to be followed for outer cartons of subsequent packs.
With regard to narcotics and psychotropic substances, export authorization should be sought from the Commissioner of Narcotics Bureau, Gwalior and import authorization from the government of the importing country .
Regarding neutral labels, a code allotment letter from the DCGI or state licensing authority should be sought.
The Indian pharmaceutical industry now ranks 3rd worldwide by volume of production thereby accounting for around 10% of world’s total pharmaceutical output in terms of volume, according to Srikant Kumar Jena, the Minister of State for Chemicals and Fertilizers, Government of India.
Globally, Indian pharma market ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms.
Indian pharma companies export their products to more than 200 countries around the globe including highly regulated markets of USA, West Europe, Japan and Australia.
The industry now produces bulk drugs or active pharmaceutical ingredients (API) belonging to all major therapeutic groups requiring complicated manufacturing technologies.
Formulations in various dosage forms are being produced in GMP compliant facilities. Strong scientific and technical manpower and pioneering work done in process development have made this possible.
Indian pharma market which is now estimated to value over to Rs. 1,00,000 crores (US $ 20 billion), has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of products, Mr Jena said in a written reply in the Lok Sabha.
The global management consulting major Mckinsey and Company has also predicted recently that the Indian pharmaceutical market is expected to touch USD 40 billion by 2015, growing at compounded annual growth rate of nearly 14% in the next few years.
Indian pharma market, which is currently valued at USD 20 billion, could see the figure almost double in next 5 years majorly propelled by the steady growth in the domestic segment.