Post-Dokalam, the Indian government is planning to take measures to reduce its dependence on China for pharmaceutical products. The recent rift between two countries has triggered the government to take actions which will help in lessening the reliance on China.
To limit the dependence on the China as well as tighten the regulatory check and balances to ensure only good quality supplies are entering the market, the health ministry along with drug regulators is planning to take a slew of measures.
India might face a major risk of severe drug shortage if India's diplomatic relations with China exacerbate further as India gets around 70-80 percent of its medicines and medical devices supplies, including raw material for pharmaceuticals (Active Pharmaceutical Ingredient) from China.
Even, National security Adviser Ajit Doval has also warned the government about India's reliance on China for API in 2014 and stressed that how spar between the countries can put the public health system of India in jeopardy.
A committee spearheaded by experts was formed to penned down the specific policy to bolster API manufacturing in India, after the Doval's warning.
The government list of regulatory and financial measures includes routine inspections of plants, higher registration charges, hike in licensing fee, tougher sourcing procedures, higher customs duty and deeper scrutiny of the supply chain.
"We do not want the trade to cease between the two countries. The idea is to regulate small foreign players who may not be supplying quality products but giving pricing advantage.
This, in turn, is hurting the interest of Indian patients as well as the industry. We want to create a level playing field for Indian companies and also ensure good quality products for Indian patients," Drugs Controller General of India (DCGI) G N Singh said.
To hike registration charges and licensing fee, the government is thinking to make changes to the Drugs and Cosmetics Rules.
The imposition of tougher norms on Chinese companies is not the solution, the government has to take some measures to foster the growth of Indian industry.
Also, according to the industry executives, Indian companies are subjected to much higher fees when they sell their products in China or in other countries.
"The measures are important to bring a parity to fee structures but it has its consequences like impact on prices and competition," says DG Shah, secretary general of Indian Pharmaceutical Alliance.
The landed price of API from China in India is 15-20% less than its production cost here, making it more viable for companies to import. Goods move also reduces importing computers from China. Instead, import from the US which is original...Chinese goods are fake.
Stop getting their network equipment they can evesdrop..NSA advisory.."Once the government strengthens the regulatory mechanism and imposes higher fee structures, a lot of fly by night operators will stop operating in this space.
While Indian players will benefit from this, it will also ensure patient safety," said Himanshu Baid, managing director of Ploy Medicure and chairman of CII Medical Technology Division.Currently, API accounts for less than 10% of India's over Rs 1 lakh crore pharmaceutical industry.
However, India was once a favored destination for sourcing low-cost, good quality raw material for manufacturing medicines. Gradually, China has taken over this bulk drug market globally in the past few years by creating huge capacities