Mumbai: Indian pharma firms nearly doubled imports of drug ingredients last year. Companies said this was to make up for shortages in local production, while analysts said it may have been aimed at cutting costs ahead of proposed curbs on drug prices, especially as a chunk of the imports came from China.
India imported active pharma ingredients (APIs) and drug intermediates worth $4.6 billion (about Rs.25,000 crore) in 2012, up from $2.9 billion in the previous year, according to data available with customs at various ports. A break-up of country-wise imports isn’t available at present.
While the exact value of the imports is yet to be compiled by the Directorate General of Foreign Trade, industry experts say the figure could be higher as some consignments have been designated as general chemicals.
“In the last couple of years, the local industry’s priority is to achieve maximum operational efficiency to mitigate the financial impacts of the new policy regime,” said an industry consultant who didn’t want to be identified. “In the pharmaceutical industry, material cost is 30-35% of sales and any savings on this will make a big difference in profitability.”
The government in December notified a new pricing policy that will bring 348 essential drugs and their formulations under price control, up from 74 bulk drugs earlier, and covering at least 40% of the medicines sold in the market. Industry expects this to reduce profit from India operations by at least 25%.
Several local drugmakers including Cipla Ltd, India’s largest by market share, have declared significant savings in material costs in the last few quarters, their results announcements show. Mint couldn’t, however, ascertain whether these savings came from cheaper imported ingredients alone, as these companies did not give a break up of material cost.
“There is a rise in imports of APIs in the last couple of years, especially from China,” said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, a lobby group of the country’s top drug manufacturers. He cited reasons other than cost.
“While there are several factors together responsible for this trend, the first and foremost is the nearly extinct penicillin production in the country,” he said. “Since penicillin and its derivatives are the base products for a broad basket of anti-infective drugs, local manufacturers have no option but to import them.”
Another reason, according to Shah, was the closure of many API manufacturers in Andhra Pradesh and Gujarat due to environmental regulations.
Earlier, the local industry used to import ingredients largely for anti-infective medicines as the production of these drugs in the country was inadequate, but it has now expanded to other therapeutic segments as well, said Shah.
Unlike the developed markets, where drug regulators such as the US Food and Drug Administration and the European Medicines Agency strictly monitor quality compliance by drugmakers and the safety of drugs in the market, in India, alerts on safety, recalls and bans are almost unheard of, said industry experts.
Although Indian law requires a foreign drug manufacturing facility to be registered with the Drug Controller General of India (DCGI) for importing drug materials to India, importers often flout the law.
Besides, Indian authorities do not have the resources to inspect overseas units that send pharma ingredients to India.
India’s drug controller general G.N. Singh said the rise in imports hasn’t led to a decline in quality.
“We are aware that the department has limited resources to keep a strict vigil at all the ports,” he added. “But we are in the process of increasing the number of inspectors, and also to give more powers to the existing staff at key sea and air ports to eliminate the entry of inferior quality material into the country.”
On average, prices of drug ingredients and intermediaries manufactured in China are 50-60% lower than the cost of APIs made in India, according to to an industry consultant.
“Cost saving is linked to the rising imports of raw material,” said P.V. Appaji, director general, Pharmaceutical Export Promotion Council of India, , a quasi-government body that promotes drug exports, but added that the local industry can’t afford to compromise on quality because of its reputation as a global manufacturer of quality generic medicines.