Ghana FDA adopts Indian pharmacopoeia standards

A panel discussion on regulations, the need for right documentation were stressed upon by the speakers.

Sairaj Iyer | The Dollar Business Bureau

 

Hudu Mogtari the CEO of Ghana FDA gave a compelling and visionary presentation during the second day proceedings of Iphex at Bombay Exhibition Center, Goregaon. Mogtari arrived at the session with a contingent of policy-makers and industrialists from Ghana. There were senior officials from the Ghana health ministry, a member of the Parliament, and the executive secretary of the pharmaceutical association of Ghana, that jubilantly backed Hudu Mogtari while he delivered his presentation.

Mogtari revealed that Ghana produced a mere 30% of domestic-healthcare needs, forcing them to depend on imports. In that respect Indian drugs are not only cost-effective but also of great quality. During his session he announced that to facilitate easier imports from India, the Ghana FDA would welcome the Indian pharmacopoeia and drug standards. “We do not have our own standard, but work with US, British and International pharmacopoeias, and from today we will also work with the Indian standards. The Indian standards are built on qualitative research and would enable our people to have safe medicines,” he said.

REGULATORY BODIES OF NIGERIA, GHANA AND EU

The FDA and pharmacopoeia agencies of Nigeria, Ghana, India and EU trade representatives actively participated in the expo.  Mogtari’s session was followed by Rametu Momodu, a hi-ranking delegate representing NAFDAC (National Agency for Food and Drug Administration and Control) of Nigeria. She spoke on the need and importance of documentation, “Documentation is critical when dealing with Nigeria. We request all exporters to send their reports in the designated formats, which are easily available on our website. Certificates of analysis are important, but adhering to pharmacopoeial standards is also necessary. Exporters should understand the ground realities and share their documentation in our formats,” she quipped.

Momodu and Mogtari were joined by pharmaceutical regulatory bodies from India. Dr. Bangarurajan of CDSCO, Drug Control departments, and Indian FDA were prominent bodies. The CDCSO is under a revamp and infusing Rs.900 crore for improvement of human resources, upgradation of laboratories, training programs for regulators, industry personnel and also undertaking the revision of drugs and cosmetic rules. These amendments also include changes to laws on clinical trials, and also schedule M. Schedule M is a stringent norm that helps pharmaceutical manufacturers to adhere quality standards. Most panelists deliberated that Schedule M is at par with standards from US and British FDA.

IN PURSUIT OF HARMONIZATION

Harmonization in standards, translated to harmonic rules that enabled easy documentation of products being exported. This was pointed as the top agenda for most attendees. “With harmonization, auditors and regulators can have a common platform for a group of countries and thereby reduce burden and pain. At the end of the day, harmonization would facilitate for efficient standardization and reduce rates of finished products,” says Dr. Ramakishan, Deputy Drug Control General of India, Government of India.

Omprakash Sadhwani, Jt Commissioner, FDA- Mumbai, echoes similar sentiments. He finds that regulators should not only work towards a harmonic standard but also have a common platform to share information and follow best protocols of working. “Regulations have evolved from needs and one cannot be testing an ingredient for all possible adulterants. Therefore, robust systems should be built, and information should be shared between all the regulators. Since we are exporting to over 200 countries, we will be in a better position to address concerns and provide right solutions to the right investigation,” he said.

According to Sudhanshu Pandey, Jt. Secretary, Ministry of Commerce, the varied and complicated supply-chain has resulted in complicated standardizations, which have not only raised costs but also increased time to market various products. Indian Pharmacopoeia (IP), has a great potential, and acceptance by multiple countries would be beneficial to importers, exporters and consumers, but to do so, intense lobbying and advocacy are the required exercises. He says, “The various elements important in advocating a pharmacopeia, should not only be initiated by the Indian government but also be perceived as beneficial by the (importing) government, consumers, people and society at large.”

The Dollar Business Bureau - Apr 29, 2016 12:00 IST
 
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