India, US agree on pharma regulation

India, US agree on pharma regulation

US and Indian drug regulators agreed on Monday to conduct joint audits and inspections of pharmaceutical manufacturing facilities in India.

The agreement came after a “free and frank” exchange of views that Margaret Hamburg, the commissioner of the US Food and Drug Administration (FDA), had with officials of the Central Drug Standard Control Organization (CDSCO) in New Delhi.  

“This is a step (for the Indian regulator) to understand global benchmarks and help Indian drug regulators meet international standards,” G.N. Singh, the drug controller general of India (DCGI), said after the meeting.

Hamburg’s visit comes after the FDA on 23 January banned a Ranbaxy Laboratories Ltd facility in Toansa, Punjab, from exporting drugs to the US. It was the fourth Ranbaxy plant to face regulatory action by the FDA.

In 2013, Ranbaxy agreed to pay a fine of $500 million to US authorities after pleading guilty to felony charges relating to the manufacturing and distribution of some adulterated drugs made at its Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) units. Other Indian drug makers have also faced penal action by FDA for not complying with prescribed standards.

Indian authorities expressed their concern over the FDA’s audit inspections of Indian pharmaceutical companies and the “disproportionate penalties” imposed in some instances, said an official close to the development.

India plans to submit a paper to the US outlining concerns over the duration of the registration process for drugs, said trade minister Anand Sharma, who met Hamburg.

“We have agreed to create an institutional framework to sensitize and educate the domestic pharmaceutical industry with regards to the certification, registration, the processes which the Indian pharmaceutical industry as a whole needs to get involved in,” Sharma told reporters.

Hamburg described the meeting as “excellent” and didn’t offer further comment.

An official said India drew the FDA commissioner’s attention to the fact that most audit inspections were not followed by discussions with firms. In some cases, clarifications were sought but even before a response, harsh decisions had been handed down.

The US is the largest market for Indian pharmaceutical firms. In the last fiscal year, India’s pharma exports increased 10% to $14.6 billion, with shipments to the US accounting for about 26%. India is the largest exporter of generic drugs to the US by volume. It has around 320 FDA-approved pharma facilities, the largest number outside the US.

India also raised the issue of the high fees for certain services rendered by the FDA and delays caused in several approval processes. – Source@Livemint.com

Inoxpa India continuously engaged in offering solutions to pharmaceutical industry by offering them its various components and Skids. One of the most commonly used Inoxpa component in pharmaceuticals are:

INLINE MIXER ME 4100ph & BLENDER M226

Inline Mixer ME 4100ph is an inline high shear mixer that offers a possibility to pump, disperse, homogenize and emulsify a wide range of products.

ME 4100ph inline mixers are most commonly used in production of ophthalmologic or contact lens solutions, syrups, pill coatings, creams, lotions and injection products.

Features of Inline Mixer ME 4100ph

1. High shear, particle reduction to the size less than 100 microns.
2. Sanitary single mechanical seal.
3. Slotted head (Standard)/ Disintegrating head.
4. Various easily interchangeable working heads.
5. Complete CIP/SIPable.
6. Drainage port connection (in the casing): ¾ “.
7. Standard connection: Clamp ISO 2852.
8. Close-coupled construction, small baseplate.
9. Motor shroud.
10. Motors: IEC B5, IP 55, F- Class Insulation.

BLENDER M - 226

M - 226 Blender is used in the pharmaceutical industry to mix solids in liquids. The most common application of Blender M – 226 is production of syrups.

Features of Blender M - 226

1. Simple and versatile assembly for quick and homogenous mixing of a great variety of solids without contact with the air.
2. Complete mixing with recirculation of the material.
3. In some applications, it can be used in line, without recirculation.
4. Sanitary design.
5. Easy assembly and disassembling of the unit.
6. Sanitary single mechanical seal.
7. Standard hopper of 40 for M – 226.