Gujarat Pharma prescribes winning the pill to the world

During the last decade, Gujarati entrepreneurs in the pharmaceutical space have gone from being local worldwide. Gujarat pharmaceutical exports have increased by 843% to US $ 5.35 billion in fiscal year 2018-19 from the relatively scarce US $ 562 million in 2005-06. In terms of rupees, exports have galloped by about 1,400%, from approximately Rs 2,500 million to Rs 37,300 million during the same period.

Gujarat's export growth has been great in the last five prosecutors. It has grown at a compound annual growth rate (CAGR) of 18.17% since 2014-15. Against this, during the same period, the national TCAC remained at 4.54%.

" Normative compliance both locally and globally, and the manufacturing of better quality products are the main driving forces of super growth in Gujarat's pharmaceutical exports, says HG Koshia, commissioner, Food and Drug Control Administration of Gujarat (FDCA). A large part of Gujarat's exports includes formulations and drugs in bulk.

GRAPHICS: Quote The inclination of Gujarati entrepreneurs to reach the export market is demonstrated by the fact that, to date, the state is home to 753 units certified according to the Good Manufacturing Practices (GMP) standards of the World Organization of Health (WHO). The United States Food and Drug Administration (USFDA) has approved 130 plants.

This shows that a growing number of state pharmaceutical companies are looking for international markets. During the last decade, Gujarat pharma the companies have become global, if they are local companies, adds the drug commissioner.

Pharmaceutical manufacturing companies based in Gujarat supply their products worldwide, including the United States, Europe, Africa, Latin America and Asian countries, among others.

A combination of factors has worked in favor of Gujarat. The entrepreneurial vision and the forecast, the favorable policies for the industry, a solid base of MSMEs, allied industries, well-developed infrastructure and a series of renowned educational institutions have shaped Gujarat's growth in pharmaceutical products. Over the years, says Sharvil Patel, managing director, Zydus Cadila. Your business in US formulations UU. It represents about half of the consolidated revenues of the main pharmaceutical companies.

The year 2018-19 was the most successful year for the company. It launched 43 new products during the year. The company also submitted 16 new files to regulatory authorities in different emerging market countries, Patel added.

According to Jayesh Desai, executive director, Torrent group , the development of ZEE, which have a good infrastructure and related facilities, are helping pharmaceutical companies in Gujarat to develop a global mindset.

Over the years, the industry has evolved to maintain high standards of manufacturing practices, and Gujarat pharmaceutical companies have received approvals from all major international regulatory bodies such as USFDA, EMA, MHRA, etc., adds Desai.

With the increase in investments in research and development, companies have been building solid pipelines to establish their presence in international markets. The international business of Torrent Pharmaceuticals has grown at a compound annual rate of 18% in the last 10 years. The company entered the US market in 2008 and currently has 90 ANDA approved and 45 pending approvals.

However, for several pharmaceutical companies, the international market was not an obvious option. There is an interesting turn in the history of pharmaceutical growth in Gujarat. Actually, it was a difficulty that became a blessing in disguise, recalls Koshia, the commissioner of the FDCA. Except for major players such as Zydus Cadila, Alembic Pharmaceuticals, Torrent Pharma and Intas Pharmaceuticals Ltd, etc., the export market was never a focus for most medium and small businesses.

It all started in 2005, when the central government made drug manufacturing standards more stringent by adding a chapter to the Drug and Cosmetics Act of 1940. These rules were close to the guidelines issued by the WHO for the manufacture of medicines. . At that time, industry players resisted a lot since they had to update their units according to the revised standards. As a regulator, we seize the opportunity and help the industry so that they can meet the new standards, Koshia adds. .

If GujFDCA had not taken their hands, around 200 units would have faced the closure, Koshia explains. At the same time, tax incentives were announced in states such as Himachal Pradesh, Sikkim. Manufacturing in these tax havens was cheaper than in non-exempt states. Given the scenario, several small and medium players were left with only two options. One was to meet higher standards (WHO standards) and take advantage of the export market. The other was to move the base to tax havens to remain competitive in the domestic market. says a source.

Pharmaceutical companies had to obtain WHO certification for the export market. Since the new rules adopted by India approached WHO standards, pharmaceutical units could prepare for export by updating their manufacturing processes to meet WHO requirements.

The future looks even brighter now. Gujarat currently has a 33% and 28% market share in pharmaceutical production and exports from India, respectively. With hundreds of new plants and a level playing field after GST, the state's participation in exports and production can reach 40% of the country's in the near future, added Viranchi Shah, president of the State Board of Gujarat, association Indian drug manufacturers.