Pharma export certificates to be issued by Centre, not states

Indian drug firms will soon have to approach the Centre rather than state authorities to get their facilities and export products certified, a move that industry players say could streamline the regulatory process for pharmaceutical sales overseas but add to delays.

The Certificate of Pharmaceutical Product (Copp) and good manufacturing practice (GMP), as laid down by the World Health Organization (WHO), will be issued by the national regulatory authority or the Drugs Controller General of India (DCGI) from 1 October, the government said in a notification last week.
Copp is mandatory in many countries that require WHO accreditation for products being imported. It will now be issued by the Central Drugs Standard Control Organisation (CDSCO).

The decision to take back the authority from the states was made during the 40th drug consultative committee (DCC) meeting in June, after several issues raised by WHO over the issuance of these certificates.“The WHO has time and again expressed concerns on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce,” the government said in the notification.

“The standard for giving Copp certificates by the states is lax and if tomorrow the WHO comes and audits the facilities, we can have problems,” said a senior official with the health ministry who did not want to be named.
Indian drug firms have had issues with foreign regulators in the past year over standards at their manufacturing plants.

A year ago, the US Food and Drug Administration (FDA) issued warning letters and import alerts on Ranbaxy Laboratories Ltd for deviations from good manufacturing practices after it audited the firm’s plants at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh.The Indian pharmaceutical exports council, Pharmexcil, says the new system would help streamline exports. “This is a welcome step by the DCGI. It will help in the international market since it maintains uniformity and transparency,” said P.V. Appaji, executive director, Pharmexcil.
There were concerns, however, that possible delays at the Centre in issuing the certificates would lead to a delay in exports, he said. Till February, India’s pharmaceutical exports were worth Rs38,000 crore, a 30% growth over the previous fiscal year.

Small scale industries, too, are worried the move could hamper their exports.
“This decision of creating non-tariff barriers of centralizing issuance of Copp is just to please the MNCs (multinational companies), to kill the export competitiveness of the small sector against public interest,” said Lalit Kumar Jain, senior vice-chairman, SME Pharma Industries Confederation (Spic).

Indian pharma industry may grow around 13% in 2009

Indian pharma industry is likely to grow by 12-13% in 2009 against earlier projections of 15% due to the global economic meltdown, a research firm has said.“In 2009, the Indian pharma industry may see a growth of 12-13%, as against our earlier forecast of 14-15%, due to the macroeconomic condition that we are having,” ORG IMS Research managing director Sameer Savkur said at a conference here.
Mumbai-based ORG IMS Research Pvt Ltd is a joint venture of AC Nielsen ORG-Marg and IMS Health, the UK.

“Global pharma growth has been declining in the past five years. There is only a small impact on India. It will see double-digit topline growth,” IMS Health vice president (Europe) Graham Lewis said.

Lewis said there has been a significant amount of restructuring in the global pharmaceutical industry, with smaller companies running out of cash and bigger companies merging with each other.

The Indian pharma industry, which grew by over 10% last year, is likely to see a marginal 1-2% spurt in growth in the next four to five years, Savkur said.
The industry grew by 10.2% in 2008 due to some extraneous circumstances, he said.
He, however, termed the Indian pharmaceutical industry as “promising”, and estimated its size to touch $30 billion by 2020.

Chronic therapy will continue to be a key growth driver, Savkur said, adding that companies are focusing on extra-urban markets as these contribute about 40% to their turnover.